LOINC Users` Guide
Transcription
LOINC Users` Guide
Logical Observation Identifiers Names and Codes (LOINC®) Users' Guide Edited by: Clem McDonald, MD, Stan Huff, MD, Jamalynne Deckard, MS, Katy Holck, MPH, Swapna Abhyankar, MD, Daniel J. Vreeman, PT, DPT Send questions and comments to: [email protected] Copyright © 1995-2016 Regenstrief Institute, Inc. and the Logical Observation Identifiers Names and Codes (LOINC) Committee All rights reserved. loinc.org i LOINC® Users’ Guide - June 2016 Table of Contents Table of Contents ......................................................................................................................................... i Copyright Notice and License .................................................................................................................. vii Notice of Third Party Content and Copyright Terms ..................................................................................................... xiv Preface.......................................................................................................................................................... 1 1 2 Introduction ......................................................................................................................................... 5 1.1 Successes ......................................................................................................................................................5 1.2 What is not part of the name ........................................................................................................................6 1.3 Scope of LOINC ..........................................................................................................................................7 1.4 The LOINC Code Identifier .........................................................................................................................7 Major “Parts” of a Test/Observation Name ..................................................................................... 8 2.1 2.1.1 2.1.2 2.1.3 2.1.4 2.1.5 2.1.6 2.2 2.2.1 2.2.2 2.2.3 2.2.4 General naming conventions ........................................................................................................................9 Abbreviations in names of component/analyte ......................................................................................................... 9 General naming rules for the component (analyte) part of the fully specified name. ............................................... 9 Punctuation in analyte names ................................................................................................................................. 11 Case insensitivity .................................................................................................................................................... 11 Roman numerals vs. Arabic numerals .................................................................................................................... 12 Exponents ............................................................................................................................................................... 12 Component/analyte (1st part) ..................................................................................................................... 12 Analyte Name (1st subpart) .................................................................................................................................... 12 Challenge test (2nd subpart) ................................................................................................................................... 13 Adjustments/corrections (3rd subpart) .................................................................................................................... 18 Distinguishing multiple values for any test via the test name (4th subpart) ............................................................ 19 2.3 Kind of Property (also called kind of quantity) (2nd part) ......................................................................... 19 2.4 Time Aspect (Point or moment in time vs. time interval) (3rd part) .......................................................... 26 2.4.1 2.5 2.5.1 2.5.2 Time Aspect Modifier............................................................................................................................................. 27 System (Sample) Type (4th part) ............................................................................................................... 28 Special issues related to XXX as a system.............................................................................................................. 30 Super system (2nd subpart)..................................................................................................................................... 31 2.6 Type of Scale (5th part).............................................................................................................................. 31 2.7 Type of Method (6th part) .......................................................................................................................... 33 2.7.1 2.7.2 2.7.3 2.7.4 2.7.5 2.7.6 2.7.7 2.7.8 DNA/RNA probes/measures................................................................................................................................... 34 PCR assays with non-probe analyte detection methods .......................................................................................... 35 Immune Assays....................................................................................................................................................... 35 Coagulation............................................................................................................................................................. 36 Stains ...................................................................................................................................................................... 36 Substrates used to measure enzyme activity ........................................................................................................... 36 Clinical measures .................................................................................................................................................... 36 Imaging studies ....................................................................................................................................................... 36 2.8 Use of curly braces {} in LOINC names.................................................................................................... 37 2.9 Short Convenient Names............................................................................................................................ 37 2.10 Long Common Names ............................................................................................................................... 37 2.11 Classes........................................................................................................................................................ 38 ii LOINC® Users’ Guide - June 2016 3 Special Cases...................................................................................................................................... 38 3.1 3.1.1 3.1.2 3.2 3.2.1 3.2.2 3.3 3.3.1 3.3.2 Value ...................................................................................................................................................................... 39 Variable (Multiple Choice) Approach .................................................................................................................... 39 Blood bank ................................................................................................................................................. 40 Panel reporting:....................................................................................................................................................... 40 Multiple answer reporting:...................................................................................................................................... 40 Immunocompetence studies (flow cytometry) ........................................................................................... 41 Number of cells containing the marker ................................................................................................................... 41 Percent of cells containing the marker .................................................................................................................... 41 3.4 General approach to microbiology results.................................................................................................. 41 3.5 Antimicrobial susceptibilities ..................................................................................................................... 44 3.6 Cell counts.................................................................................................................................................. 44 3.7 Skin tests .................................................................................................................................................... 45 3.8 Toxicology – Drug of Abuse Screening and Confirmation ........................................................................ 45 3.8.1 3.8.2 3.8.3 3.8.4 3.8.5 3.8.6 3.9 3.9.1 3.9.2 3.9.3 3.9.4 3.9.5 3.9.6 3.9.7 4 Findings viewed as variables or as values .................................................................................................. 38 Toxicology drug groups.......................................................................................................................................... 46 Cutoffs .................................................................................................................................................................... 47 Reporting the method used for screen and confirm ................................................................................................ 47 Individual drug/metabolite test results .................................................................................................................... 48 Naming issues ......................................................................................................................................................... 49 Summary ................................................................................................................................................................ 49 Molecular Genetics LOINC Naming ......................................................................................................... 49 Introduction ............................................................................................................................................................ 49 Brief review of molecular genetics terminology ..................................................................................................... 50 Background on molecular genetics testing methods ............................................................................................... 50 General molecular genetics naming rules ............................................................................................................... 51 Infectious diseases .................................................................................................................................................. 53 Genetic conditions .................................................................................................................................................. 54 Identity testing ........................................................................................................................................................ 59 3.10 HLA allele and antigen nomenclature ........................................................................................................ 60 3.11 Allergy Testing .......................................................................................................................................... 60 Clinical observations and measures ................................................................................................ 62 4.1 Introduction ................................................................................................................................................ 62 4.2 Atomic versus molecular (pre-coordinated names) .................................................................................... 64 4.3 Radiology Reports...................................................................................................................................... 65 4.3.1 4.3.2 4.3.3 In-progress changes coming through our collaboration with the RSNA ................................................................. 66 Diagnostic Radiology Reports ................................................................................................................................ 66 Interventional Radiology Reports ........................................................................................................................... 73 5 Tumor registry .................................................................................................................................. 73 6 Claims attachments ........................................................................................................................... 74 7 LOINC Document Ontology ............................................................................................................ 74 7.1 Introduction to the use of LOINC document type codes ............................................................................ 74 7.2 Relationship to other standards .................................................................................................................. 75 7.3 Elements of Document Type codes ............................................................................................................ 75 iii LOINC® Users’ Guide - June 2016 7.4 Rules for Creating Clinical Notes from Multiple Components .................................................................. 83 7.4.1 8 Exceptions to Rules for Creating Clinical Notes .................................................................................................... 84 7.5 Document Ontology Content in the LOINC Distribution .......................................................................... 85 7.6 Future Work ............................................................................................................................................... 85 7.7 Proposing new LOINC document terms .................................................................................................... 85 Panels (Batteries) .............................................................................................................................. 85 8.1 Goals .......................................................................................................................................................... 86 8.2 Types of results found in panels ................................................................................................................. 86 8.2.1 8.2.2 8.2.3 8.2.4 8.3 Primary measurements or observations .................................................................................................................. 86 Derived observations .............................................................................................................................................. 87 Ask at order entry (AOE) questions and other associated observations.................................................................. 87 Impressions, interpretations, and comments ........................................................................................................... 87 LOINC rules for panel names .................................................................................................................... 87 8.3.1 8.3.2 8.3.3 8.3.4 8.4 Component ............................................................................................................................................................. 87 Property and Scale .................................................................................................................................................. 88 Time Aspect and System ........................................................................................................................................ 88 Examples of LOINC Panel names .......................................................................................................................... 88 Representing conditionality........................................................................................................................ 88 8.4.1 8.5 Lupus anticoagulant (LA) testing as an example of complex conditionality .......................................................... 90 Approach to creating and defining distinct panels in LOINC .................................................................... 91 8.5.1 8.5.2 8.5.3 9 General approach .................................................................................................................................................... 91 Preference for methodless panel definitions ........................................................................................................... 92 Special cases where enumeration of child elements is not practical ....................................................................... 93 Evolving principles for naming collections ..................................................................................... 93 9.1 Goals and general approach ....................................................................................................................... 93 9.2 Collections as orders and observations ...................................................................................................... 94 9.3 LOINC SCALE for collections .................................................................................................................. 94 9.4 Examples of proposed changes according to new policy ........................................................................... 94 10 Additional Content in the LOINC Distribution ......................................................................... 95 10.1 LOINC Answers and Answer Lists ............................................................................................................ 95 10.1.1 Null flavors in LOINC answer lists ................................................................................................................... 96 10.2 LOINC Parts and Part Hierarchies ............................................................................................................. 96 10.3 Use of the ORDER_OBS field for LOINC terms ...................................................................................... 96 11 Standardized Assessment Measures ............................................................................................ 97 11.1 Introduction ................................................................................................................................................ 97 11.2 Consolidated Health Informatics endorsement .......................................................................................... 98 11.3 LOINC Representation............................................................................................................................... 98 11.3.1 11.3.2 11.3.3 11.3.4 11.3.5 11.3.6 Naming rules and conventions for names of collection terms (e.g. a panel, survey instrument) ........................ 98 Attributes of the LOINC terms for individual questions or variables ................................................................ 98 Structured answer lists ....................................................................................................................................... 99 Attributes of items that vary depending on the parent collection ....................................................................... 99 Choosing the “display text” for a question or variable....................................................................................... 99 Type of Method (6th part) for a question or variable ....................................................................................... 100 iv LOINC® Users’ Guide - June 2016 11.4 12 Assessment Content in the LOINC Distribution ...................................................................................... 100 Editorial Policies and Procedures .............................................................................................. 101 12.1 Concept orientation and LOINC name changes ....................................................................................... 101 12.2 Classification of LOINC term status ........................................................................................................ 101 12.3 Concept persistence and term deprecation ............................................................................................... 103 13 Recommendations for Best Practices in Using and Mapping to LOINC ............................... 103 13.1 Business rules for users mapping their local panels to LOINC panels ..................................................... 103 13.1.1 13.1.2 13.1.3 13.1.4 13.1.5 13.1.6 13.1.7 13.1.8 13.1.9 13.2 Must contain all of the required elements ........................................................................................................ 103 No extra primary measurements ...................................................................................................................... 103 Optional elements are optional ........................................................................................................................ 103 Substitutions related to Method ....................................................................................................................... 103 Substitutions for mass versus substance Properties.......................................................................................... 104 No substitutions of quantitative for qualitative (and vice versa) ...................................................................... 104 Pay attention to reflex components .................................................................................................................. 104 Special case of differential counts (including conventions for not reporting zero counts) ............................... 105 Panels with only narrative definitions of the elements they should contain ..................................................... 105 Examples of applying the business rules for users mapping their local panels to LOINC panels............ 105 13.2.1 13.2.2 13.2.3 Comparison Panel: Varicella zoster virus IgG and IgM panel - Serum (LOINC # 45063-5)........................... 105 Comparison Panel: Creatine kinase panel - Serum or Plasma (LOINC # 24335-2) ......................................... 105 Comparison Panel: Drugs of abuse 5 panel - Urine by Screen method (LOINC # 65750-2) ........................... 106 13.3 Querying LOINC and creating intensional value set definitions based on LOINC database structure ... 107 13.4 LOINC term names in HL7 messages ...................................................................................................... 107 13.5 Updating to new versions of LOINC ....................................................................................................... 107 13.6 Using a URI to identify LOINC concepts as resources in RDF ............................................................... 108 Appendix A - LOINC Database Structure ........................................................................................... 109 Appendix B - Classes .............................................................................................................................. 113 Appendix C - Calculating Mod 10 Check Digits .................................................................................. 121 Appendix D - Procedure for Submitting Additions/Changes to LOINC ........................................... 122 Appendix E - Examples for LOINC Property Matching .................................................................... 125 Appendix F – Example Acronyms used in LOINC .............................................................................. 129 Appendix G – LOINC Technical Briefs ................................................................................................ 132 D-DIMER .............................................................................................................................................................. 133 Cockcroft-Gault formula for estimating creatinine clearance, Schwartz equation for Glomerular Filtration Rate and MDRD formulae ............................................................................................................................................. 137 Inducible Clindamycin Resistance in Staphylococcus and Streptococcus ............................................................ 141 The KIR Gene Family ........................................................................................................................................... 142 Oxygen Saturation and LOINC® .......................................................................................................................... 143 Nomenclature of Salmonella Species, Subspecies, and Serovars .......................................................................... 146 v LOINC® Users’ Guide - June 2016 Segmented Neutrophils Versus Polymorphonuclear WBC ................................................................................... 148 Vitamin D .............................................................................................................................................................. 149 Free Thyroxine Index Variants.............................................................................................................................. 152 Appendix H - LOINC Committee Members ........................................................................................ 154 RadLex-LOINC Radiology Playbook User Guide .......................................................................... Annex Tables Table 1: Hierarchical Structure of Fully Specified Analyte Names ........................................................................8 Table 2: Example Component Abbreviations ...........................................................................................................9 Table 3: Example Case Specifying Conventions ..................................................................................................... 11 Table 4: Example Time Delay Post Challenge ........................................................................................................ 14 Table 5: Example Challenge Subparts..................................................................................................................... 15 Table 6: Example Route Abbreviations for Challenge Part .................................................................................. 15 Table 7: Example Nature of Challenge .................................................................................................................... 16 Table 8: Example LOINC properties....................................................................................................................... 21 Table 9: Example Duration Categories ................................................................................................................... 27 Table 10: Time Aspect Modifier Codes ................................................................................................................... 27 Table 11: Example Laboratory System/Sample Types .......................................................................................... 29 Table 12: Type of Scale ............................................................................................................................................. 31 Table 13: Laboratory Method Type Abbreviations................................................................................................ 33 Table 14a: Examples of specific methods that would be classed as target amplified DNA/RNA ....................... 34 Table 14b: Examples of specific methods that would be defined in LOINC as signal amplification methods .. 35 Table 15: Example Culture Results ......................................................................................................................... 43 Table 16: Drug Susceptibility Methods ................................................................................................................... 44 Table 17: Drug of Abuse Methods ........................................................................................................................... 45 Table 18: Four types of nomenclatures for identifying the location of a genetic defect ...................................... 51 Table 19: List of single letter amino acid codes ...................................................................................................... 52 Table 20: Example subjects covered in clinical LOINC ......................................................................................... 63 Table 21: Examples of Pre-Coordinated Names ..................................................................................................... 65 Table 22: Example Clinical Notes ............................................................................................................................ 74 Table 23. Document Ontology LOINC Naming Rules ........................................................................................... 83 Table 24. Example Document Ontology LOINC Codes ......................................................................................... 84 Table 25. LOINC Code Exceptions to Creating a General Clinical Document Code .......................................... 84 Table 26. LOINC Codes with only a Kind of Document ........................................................................................ 85 Table 27: Examples of LOINC Panel Names (Order Set Names) ......................................................................... 88 Table 28: Example Order Sets.................................................................................................................................. 89 Table 29: Options for Term Conditionality within Panels ..................................................................................... 89 Table 30: Example of Proposed Changes ................................................................................................................ 94 Table 31a: LOINC Table Structure ....................................................................................................................... 109 Table 31b: MAP_TO Table Structure ................................................................................................................... 112 Table 31c: Source Organization Table Structure ................................................................................................. 112 Table 32a: Clinical Term Classes ........................................................................................................................... 113 Table 32b: Laboratory Term Classes .................................................................................................................... 116 Table 32c: Attachment Term Classes .................................................................................................................... 117 Table 32d: Survey Term Classes ............................................................................................................................ 118 Table 33: Example Acronyms used in LOINC...................................................................................................... 129 vi LOINC® Users’ Guide - June 2016 Copyright Notice and License The LOINC® codes, LOINC® table (regardless of format), LOINC® Release Notes, LOINC® Changes File, and LOINC® Users' Guide are copyright © 1995-2016, Regenstrief Institute, Inc. and the Logical Observation Identifiers Names and Codes (LOINC) Committee. All rights reserved. The RELMA® program, RELMA® database and associated search index files (subject to the copyright above with respect to the LOINC® codes and LOINC® table included therein), RELMA® Community Mapping Feature Database, RELMA® Release Notes, and RELMA® Users' Manual are copyright © 1995-2016, Regenstrief Institute, Inc. All rights reserved. The LOINC® panels and forms file; LOINC® document ontology file; and the LOINC® hierarchies, LOINC® linguistic variants files, LOINC/RSNA Radiology Playbook, and LOINC/IEEE Medical Device Code Mapping Table (all subject to the copyright above with respect to the LOINC® codes and LOINC® table to the extent included therein), are copyright © 1995-2016, Regenstrief Institute, Inc. All rights reserved. LOINC® and RELMA® are registered United States trademarks of Regenstrief Institute, Inc. Permission is hereby granted in perpetuity, without payment of license fees or royalties, to use, copy, or distribute the RELMA® program, RELMA® Users' Manual, RELMA® Release Notes, RELMA® database and associated search index files, LOINC® codes, LOINC® Users' Guide, LOINC® table (in all formats in which it is distributed by Regenstrief Institute, Inc. and the LOINC Committee), LOINC® Release Notes, LOINC® Changes File, LOINC® panels and forms file, LOINC® document ontology file, LOINC® hierarchies file, LOINC® linguistic variants file, LOINC/RSNA Radiology Playbook, and LOINC/IEEE Medical Device Code Mapping Table (collectively, the "Licensed Materials") for any commercial or non-commercial purpose, subject to the following terms and conditions: 1. To prevent the dilution of the purpose of the LOINC codes and LOINC table of providing a definitive standard for identifying clinical information in electronic reports, users shall not use any of the Licensed Materials for the purpose of developing or promulgating a different standard for identifying patient observations, such as laboratory test results; other diagnostic service test results; clinical observations and measurements; reports produced by clinicians and diagnostic services about patients; panels, forms, and collections that define aggregations of these observations; and orders for these entities in electronic reports and messages. 2. If the user elects to use the RELMA program, users receive the full RELMA database and associated search index files with the RELMA program, including the LOINC table and other database tables comprising the RELMA database. In addition to its use with the RELMA program, users may use the LOINC table by itself and may modify the LOINC table as permitted herein. Users may not use or modify the other database tables from the RELMA database or the associated search index files except in conjunction with their authorized use of the RELMA program, unless prior written permission is granted by the vii LOINC® Users’ Guide - June 2016 Regenstrief Institute, Inc. To request written permission, please contact [email protected]. The RELMA program also provides access to certain internetbased content copyrighted by Regenstrief Institute, Inc. No additional permission to modify or distribute this internet-based content is granted through the user’s use of the RELMA program. 3. The RELMA program also includes the RELMA Community Mappings feature and access to the RELMA Community Mappings feature database. The accuracy and completeness of the information in the RELMA Community Mappings feature is not verified by Regenstrief Institute, Inc. or the LOINC Committee. Access to the RELMA Community Mappings feature is enabled by a user authentication from the RELMA login screen. If a user wishes to opt out of the RELMA Community Mappings feature, they can simply use RELMA without logging in. 1. By using the RELMA Community Mappings feature, users agree as follows: i. Users may not copy, distribute, or share access to the information provided by the RELMA Community Mappings feature. ii. Users accept the risk of using the information provided by the RELMA Community Mappings feature, recognize that such information is submitted by other users, and understand that neither Regenstrief Institute, Inc. nor the LOINC Committee are liable for the information provided by the RELMA Community Mappings feature. iii. Regenstrief Institute, Inc. may contact users regarding: 1. Use of the RELMA Community Mappings feature; 2. Submission requests for additional information; and 3. Any mapping submissions that the user makes to the RELMA Community Mappings feature database; iv. Others may contact user about submissions made to the RELMA Community Mappings feature database; v. User will make reasonable efforts to submit user’s mappings back to the RELMA Community Mappings feature database, which may contain the following information (as applicable): 1. Local battery/panel/test code 2. Local battery/panel/test name/description 3. Units of Measure 4. LOINC code to which it is mapped 5. Date of mapping 6. Language of test names 7. Version of LOINC used to do the mapping 8. Contact information; vi. If a user submits mappings on behalf of an organization, the user represents that the user has the authority to submit the mappings and to agree to these terms on behalf of user’s organization. vii. If a user submits mappings back to the RELMA Community Mappings feature database, then the user hereby grants, on behalf of themselves and user’s organization, Regenstrief Institute, Inc. a non-exclusive license without payment or fees to submitted mappings in perpetuity for purposes viii LOINC® Users’ Guide - June 2016 4. 5. 6. 7. 8. related to LOINC, RELMA, and Regenstrief Institute Inc.’s mission, including, but not limited to: 1. Modifying the information; 2. Making information publicly available; 3. Performing aggregate analysis; 4. Conducting and publishing research that does not identify user or user’s organization by name; 5. Developing and enhancing LOINC and associated software tools. Users shall not change the meaning of any of the LOINC codes. Users shall not change the name of, or any contents of, any fields in the LOINC table. Users may add new fields to the LOINC table to attach additional information to existing LOINC records. Users shall not change the content or structure of the LOINC document ontology file or the LOINC panels and forms from the LOINC panels and forms file, but may notify the Regenstrief Institute, Inc. of any potential inconsistencies or corrections needed by contacting [email protected]. Users shall not use the LOINC parts or LOINC part hierarchies in any manner except as they are presented in the Licensed Materials (and/or in other formats of distribution approved by Regenstrief Institute, Inc.) to organize or be constituents of LOINC terms. LOINC parts and LOINC part hierarchies shall neither be used as a “standalone” terminology nor apart from LOINC terms. User understands that LOINC parts and LOINC part hierarchies are subject to change, addition, modification, or deletion, and are not strictly managed under the same policies as LOINC terms. A user may delete records from the LOINC table to deal with the user's local requirements. A user also may add new records to the LOINC table to deal with the users' local requirements, provided that if new records are added, any new entry in the LOINC_NUM field of such new records must contain a leading alphabetic "X" so that the new codes and records cannot be confused with existing LOINC codes or new LOINC codes as they are defined in later releases of the LOINC table. Records deleted or added by users to deal with local requirements are not reflected in the official LOINC table maintained by the Regenstrief Institute, Inc. and the LOINC Committee. Users must also make reasonable efforts to submit requests to LOINC for new records to cover observations that are not found in the LOINC table in order to minimize the need for Xcodes. LOINC codes and other information from the LOINC table may be used in electronic messages for laboratory test results and clinical observations such as HL7 ORU messages, without the need to include this Copyright Notice and License or a reference thereto in the message (and without the need to include all fields required by Section 9 hereof). When the LOINC code (from the LOINC_NUM field) is included in the message, users are encouraged, but not required, to include the corresponding LOINC short name (from the SHORTNAME field) or the LOINC long common name (from the LONG_COMMON_NAME field) in the message if the message provides a place for a text name representation of the code. Users may make and distribute an unlimited number of copies of the Licensed Materials. Each copy thereof must include this Copyright Notice and License, and must include the appropriate version number of the Licensed Materials if the Licensed Materials have a version number, or the release date if the Licensed Materials do not have a version ix LOINC® Users’ Guide - June 2016 number. This Copyright Notice and License must appear on every printed copy of the LOINC table. Where the Licensed Materials are distributed on a fixed storage medium (such as CD-ROM), a printed copy of this Copyright Notice and License must be included on or with the storage medium, and a text file containing this information also must be stored on the storage medium in a file called "license.txt". Where the Licensed Materials are distributed via the Internet, this Copyright Notice and License must be accessible on the same Internet page from which the Licensed Materials are available for download. This Copyright Notice and License must appear verbatim on every electronic or printed copy of the RELMA Users' Manual and the LOINC Users' Guide. The RELMA Users' Manual and the LOINC Users' Guide may not be modified, nor may derivative works of the RELMA Users' Manual or LOINC Users' Guide be created, without the prior written permission of the Regenstrief Institute, Inc. To request written permission, please contact [email protected]. The Regenstrief Institute retains the right to approve any modification to, or derivative work of, the RELMA Users' Manual or the LOINC Users' Guide. 9. Subject to Section 1 and the other restrictions hereof, users may incorporate portions of the LOINC table, LOINC panels and forms file, LOINC document ontology file, LOINC hierarchies file, LOINC linguistic variants file, LOINC/RSNA Radiology Playbook, and LOINC/IEEE Medical Device Code Mapping Table into another master term dictionary (e.g. laboratory test definition database), or software program for distribution outside of the user's corporation or organization, provided that any such master term dictionary or software program includes the following fields reproduced in their entirety from the LOINC table: LOINC_NUM, COMPONENT, PROPERTY, TIME_ASPCT, SYSTEM, SCALE_TYP, METHOD_TYP, STATUS, and SHORTNAME. Users are also required to either: (1) include the EXTERNAL_COPYRIGHT_NOTICE or (2) delete the rows that include third party copyrighted content (e.g., third party survey instruments and answers). If third party content is included, users are required to comply with any such third party copyright license terms. Users are encouraged, but not required, to also include the RelatedNames2 and the LONG_COMMON_NAME in any such database. Further description of these fields is provided in Appendix A of the LOINC Users' Guide. Every copy of the LOINC table, LOINC panels and forms file, LOINC document ontology file, LOINC hierarchies file, LOINC linguistic variants file, LOINC/RSNA Radiology Playbook, and/or LOINC/IEEE Medical Device Code Mapping Table incorporated into or distributed in conjunction with another database or software program must include the following notice: "This product includes all or a portion of the LOINC® table, LOINC panels and forms file, LOINC document ontology file, LOINC hierarchies file, LOINC linguistic variants file, LOINC/RSNA Radiology Playbook, and/or LOINC/IEEE Medical Device Code Mapping Table or is derived from one or more of the foregoing, subject to a license from Regenstrief Institute, Inc. Your use of the LOINC table, LOINC codes, LOINC panels and forms file, LOINC document ontology file, LOINC hierarchies file, LOINC linguistic variants file, LOINC/RSNA Radiology Playbook, and LOINC/IEEE Medical Device Code Mapping Table also is subject to this license, a copy of which is available at http://loinc.org/terms-of-use. The current complete LOINC table, LOINC Users' x LOINC® Users’ Guide - June 2016 Guide, LOINC panels and forms file, LOINC document ontology file, LOINC hierarchies file, LOINC linguistic variants file, LOINC/RSNA Radiology Playbook, and LOINC/IEEE Medical Device Code Mapping Table are available for download at http://loinc.org. The LOINC table and LOINC codes are copyright © 1995-2016, Regenstrief Institute, Inc. and the Logical Observation Identifiers Names and Codes (LOINC) Committee. The LOINC panels and forms file, LOINC document ontology file, LOINC hierarchies file, LOINC linguistic variants file, and LOINC/RSNA Radiology Playbook, and LOINC/IEEE Medical Device Code Mapping Table are copyright © 1995-2016, Regenstrief Institute, Inc. All rights reserved. THE LOINC TABLE (IN ALL FORMATS), LOINC PANELS AND FORMS FILE, LOINC DOCUMENT ONTOLOGY FILE, LOINC HIERARCHIES FILES, LOINC LINGUISTIC VARIANTS FILE, LOINC/RSNA RADIOLOGY PLAYBOOK, AND LOINC/IEEE MEDICAL DEVICE CODE MAPPING TABLE ARE PROVIDED "AS IS." ANY EXPRESS OR IMPLIED WARRANTIES ARE DISCLAIMED, INCLUDING, BUT NOT LIMITED TO, THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE. LOINC® is a registered United States trademark of Regenstrief Institute, Inc. A small portion of the LOINC table may include content (e.g., survey instruments) that is subject to copyrights owned by third parties. Such content has been mapped to LOINC terms under applicable copyright and terms of use. Notice of such third party copyright and license terms would need to be included if such content is included." If the master term dictionary or software program containing the LOINC table, LOINC panels and forms file, LOINC document ontology file, LOINC hierarchies file, LOINC linguistic variants file, LOINC/RSNA Radiology Playbook, and/or LOINC/IEEE Medical Device Code Mapping Table is distributed with a printed license, this statement must appear in the printed license. Where the master term dictionary or software program containing the LOINC table, LOINC panels and forms file, LOINC document ontology file, LOINC hierarchies file, LOINC linguistic variants file, LOINC/RSNA Radiology Playbook, and/or LOINC/IEEE Medical Device Code Mapping Table is distributed on a fixed storage medium, a text file containing this information also must be stored on the storage medium in a file called "LOINC_short_license.txt". Where the master term dictionary or software program containing the LOINC table, LOINC panels and forms file, LOINC document ontology file, LOINC hierarchies file, LOINC linguistic variants file, LOINC/RSNA Radiology Playbook, and/or LOINC/IEEE Medical Device Code Mapping Table is distributed via the Internet, this information must be accessible on the same Internet page from which the product is available for download. 10. Subject to Section 1 and the other restrictions hereof, users may incorporate portions of the LOINC table, LOINC panels and forms file, LOINC linguistic variants file, LOINC/RSNA Radiology Playbook, and/or LOINC/IEEE Medical Device Code Mapping Table into another document (e.g., an implementation guide or other technical specification) for distribution outside of the user's corporation or organization, subject to these terms: xi LOINC® Users’ Guide - June 2016 a. Every copy of the document that contains portions of the LOINC table, LOINC panels and forms file, LOINC linguistic variants file, LOINC/RSNA Radiology Playbook, and/or LOINC/IEEE Medical Device Code Mapping Table must include the following notice: "This material contains content from LOINC® (http://loinc.org). The LOINC table, LOINC codes, LOINC panels and forms file, LOINC linguistic variants file, LOINC/RSNA Radiology Playbook, and LOINC/IEEE Medical Device Code Mapping Table are copyright © 19952016, Regenstrief Institute, Inc. and the Logical Observation Identifiers Names and Codes (LOINC) Committee and is available at no cost under the license at http://loinc.org/terms-of-use.” Every document (including, but not limited to, a webpage) containing portions of the licensed material that is made available by a website or mobile device application must contain the notice set forth above. b. Users are strongly encouraged, but not required, to indicate the appropriate version number of the Licensed Material used. c. Any information in the document that is extracted from the LOINC table, LOINC panels and forms file, LOINC linguistic variants file, LOINC/RSNA Radiology Playbook, and/or LOINC/IEEE Medical Device Code Mapping Table must always be associated with the corresponding LOINC code. d. Along with the LOINC code, users are required to include one of the following LOINC display names from either the LOINC table or the LOINC linguistic variants file (as available): i. The fully-specified name, which includes the information from the COMPONENT, PROPERTY, TIME_ASPCT, SYSTEM, SCALE_TYP, and METHOD_TYP fields; ii. The LOINC short name (from the SHORTNAME field); or iii. The LOINC long common name (from the LONG_COMMON_NAME field). e. Users are also required to either: i. Include the EXTERNAL_COPYRIGHT_NOTICE, or ii. Exclude the rows that include third party copyrighted content (e.g., third party survey instruments and answers). If third party content is included, users are required to comply with any such third party copyright license terms. 11. Use and distribution of the Licensed Materials in ways that are not specifically discussed herein shall always be accompanied by the notice provided in Section 9 hereof. The guidelines for providing the notice that are contained in the last paragraph of Section 9 also shall apply. If a user has a question about whether a particular use of any of the Licensed Materials is permissible, the user is invited to contact the Regenstrief Institute, Inc. by e-mail at [email protected]. 12. If the user desires to translate any of the Licensed Materials into a language other than English, then user shall notify Regenstrief Institute, Inc. via email at [email protected]. Any such translation is a derivative work, and the user agrees and xii LOINC® Users’ Guide - June 2016 does hereby assign all right, title and interest in and to such derivative work: (1) to Regenstrief Institute, Inc. and the LOINC Committee if the translation is a derivative of the LOINC codes, LOINC Users' Guide, or LOINC table, and (2) to Regenstrief Institute, Inc. if the translation is a derivative work of the RELMA program, LOINC panels and forms file, LOINC document ontology file, LOINC hierarchies file, LOINC linguistic variants file, LOINC/RSNA Radiology Playbook, LOINC/IEEE Medical Device Code Mapping Table, RELMA Users' Manual, RELMA database or associated search index files. 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The current complete UCUM table, UCUM Specification are available for download at http://unitsofmeasure.org. The UCUM table and UCUM codes are copyright © 1995-2016, Regenstrief Institute, Inc. and the Unified Codes for Units of Measures (UCUM) Organization. All rights reserved. THE UCUM TABLE (IN ALL FORMATS), UCUM DEFINITIONS, AND SPECIFICATION ARE PROVIDED "AS IS." ANY EXPRESS OR IMPLIED xv LOINC® Users’ Guide - June 2016 WARRANTIES ARE DISCLAIMED, INCLUDING, BUT NOT LIMITED TO, THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE. xvi Preface LOINC provides a set of universal names and ID codes for identifying laboratory and clinical test results.1,2 LOINC facilitates the exchange and pooling of results, such as blood hemoglobin, serum potassium, or vital signs, for clinical care, outcomes management, and research. Currently, many laboratories use ASTM 12383 or its sister standard, HL74, to send laboratory results electronically from production laboratories to clinical care systems in hospitals. Most laboratories identify tests in HL7 messages by means of their internal (and idiosyncratic) code values. Receiving medical information systems cannot fully “understand” the results they receive unless they either adopt the producer's laboratory codes (which is impossible if information system receives results from multiple source laboratories, e.g., the hospital lab, the local commercial lab, and a nursing home lab), or invest in the work to map each laboratory's coding system to their internal code system.5 If medical information producers who wish to communicate with each other adopt LOINC codes to identify their results in data transmissions, this problem would disappear. The receiving system with LOINC codes in its master vocabulary file would be able to understand and properly file HL7 results messages that identified clinical observations via LOINC codes. Similarly, if test and observation codes were reported test with the LOINC codes, government agencies would be able to pool results for tests from many sites for research management and public health purpose. The LOINC codes (and names) for test observations should be of interest to hospitals, clinical laboratories, doctors' offices, state health departments, governmental health care providers, third-party payers, and organizations responsible for quality assurance and utilization review. The LOINC codes are not intended to transmit all possible information about a test or observation. They are only intended to identify the test result or clinical observation. Other fields in the message can transmit the identity of the source laboratory and special details about the sample. (For instance, the result code may identify a blood culture, but the message source code can be more specific and identify the sample as pump blood.) The level of detail in the LOINC definitions was intended to distinguish tests that are usually distinguished as separate test results within the master file of existing laboratory systems. Indeed, at the outset, we used the master files from seven U.S. laboratories to shape this effort, and requests from commercial labs and hospitals continue to shape the content of the LOINC effort. Each LOINC record corresponds to a single test result or panel. The record includes fields for specifying: 1. Component (analyte) - e.g., potassium, hemoglobin, hepatitis C antigen. 2. Property measured - e.g., a mass concentration, enzyme activity (catalytic rate). 3. Timing - i.e., whether the measurement is an observation at a moment of time, or an observation integrated over an extended duration of time - e.g., 24-hour urine. 4. The type of sample - e.g., urine, blood. 5. The type of scale - e.g., whether the measurement is quantitative (a true measurement) ordinal (a 1 Forrey AW, McDonald CJ, DeMoor G, Huff, SM, Leavelle D, Leland D, Fiers T, Charles L, Stalling F, Tullis A, et. al. The logical observation identifier names and codes (LOINC) database: A public use set of codes and names for electronic reporting of clinical laboratory results. Clinical Chemistry 1996;42:81-90. 2 McDonald CJ, Huff SM, Suico JG, Hill G, Leavelle D, Aller R, Forrey A, Mercer K, DeMoor G, Hook J, Williams W, Case J, Maloney P. LOINC, a universal standard for identifying laboratory observations: A 5-Year update. Clinical Chemistry 2003;49:624-633. 3 ASTM E1238-94. Standard Specification for Transferring Clinical Observations Between Independent Computer Systems. Philadelphia: American Society for Testing Materials; 1994. 4 Health Level Seven. An application protocol for electronic data exchange in healthcare environments. Version 2.3 Ann Arbor, MI: Health Level Seven, Inc.; 1997. 5 McDonald CJ, Park BH, Blevins L. Grocers, physicians, and electronic data processing. AMA Continuing Medical Education Newsletter 1983;1:5-8. 1 LOINC® Users’ Guide - June 2016 ranked set of options), nominal (e.g., E. coli; Staphylococcus aureus), or narrative (e.g., dictation results from x-rays). 6. Where relevant, the method used to produce the result or other observation. It also contains information about the amount, route, and timing of physiologic or pharmacologic challenges. For example, a glucose tolerance test could be expressed in LOINC as Glucose^1H post 100 g glucose PO. LOINC does not usually include the method in the name for chemistry tests, where tests are more often standardized to normalized methods; they do include methods for most serological tests and coagulation studies. This same principle is usually reflected in the master files of existing laboratories. Of course, the method can always be reported as a separate item of information in a result message, regardless of whether it is part of the test name. We used many sources for constructing the database, including the Silver Book from the International Union of Pure and Applied Chemistry (IUPAC) and the International Federation of Clinical Chemistry (IFCC), 6 textbooks of clinical pathology (e.g., Henry7 and Tietz8), the expertise and work of the LOINC members, and EUCLIDES. We have also reviewed the master test files of seven sources (Indiana University/Regenstrief, University of Utah, Association of Regional and University Pathologists (ARUP), Mayo Medical Laboratories, LDS Hospital in Salt Lake City, the Department of Veterans Affairs, Quest Diagnostics, and University of Washington). This has been an empirical effort. Our goal is to provide codes that correspond to the concepts in real world laboratories’ and clinical departments’ master files. LOINC includes fields for each of the six parts of the name. In addition, it also contains short names (as of the August 2002 version for laboratory tests), related words, synonyms, and comments for all observations. Related words (synonyms) are included to facilitate searches for individual laboratory test and clinical observation results. We have defined fields in LOINC for a number of data elements, e.g., typical units, sample normal ranges, but most of those fields are only partially populated. In a few cases, we have suggested standard answer lists for tests whose results are usually reported as codes. LOINC is an ongoing project. We have established guidelines for users who wish to request additions and changes, which are detailed in Appendix D. For some kind of tests and observations, the database provides several ways to report values. For example, blood cell antigens might be presented as a “panel” with separate “tests” which report each possible antigen as present or absent if the test is to establish paternity; for cross matching, the result would be reported as a list of antigens found. We try to provide for both methods of reporting in LOINC by including codes for both types of test identifiers. Laboratories and managers of medical records systems should record the LOINC codes as attributes of their existing test/observation master files. They should also use the LOINC codes and names in the OBSERVATION ID field (OBX-3) of the ASTM and HL7 OBX segment and the corresponding CEN TC251 and DICOM messages to identify laboratory results. The overall organization of LOINC is divided first into four categories, “lab”, “clinical”, “attachments” and “surveys”. (This split is recorded in CLASSTYPE field of the LOINC Table.) The laboratory portion is further divided into the usual categories of chemistry, hematology, serology, microbiology (which 6 International Union of Pure and Applied Chemistry/International Federation of Clinical Chemistry. The Silver Book: Compendium of terminology and nomenclature of properties in clinical laboratory sciences. Oxford: Blackwell Scientific Publishers; 1995. 7 Henry JB. Clinical Diagnosis and Management by Laboratory Methods. Philadelphia:W.B. Saunders; 1994. 8 Burtis CA, Ashwood ER (editors). Tietz Textbook of Clinical Chemistry, 2nd ed. Philadelphia:W.B. Saunders; 1994. 2 LOINC® Users’ Guide - June 2016 includes parasitology and virology), and toxicology. We have separated antibiotic susceptibilities into their own category. The clinical portion of LOINC contains entries for vital signs, hemodynamics, intake/output, EKG, obstetric ultrasound, cardiac echo, urologic imaging, gastroendoscopic procedures, pulmonary ventilator management, and other clinical observations. Appendix B lists these classes in more detail. There is nothing sacred about these categories, and you are free to sort the database by whatever class is convenient for your application. The Regenstrief Institute maintains LOINC and makes it available in a number of file formats. LOINC and the related files (such as this document) are copyrighted to assure that multiple variants of the standard do not emerge. Having many variants would defeat the purpose of a universal identifier for test results. LOINC is made available at no cost worldwide under the license at http://loinc.org/terms-of-use. The LOINC Table, supporting documentation and supplemental files, and the RELMA® mapping program are all made available by the Regenstrief Institute on the LOINC website (http://loinc.org). The primary files in the LOINC distribution are listed below. LOINC Table – Microsoft Access Format All the fields of the LOINC Table available in a Microsoft Access™ database format. LOINC Table – Text Format (Comma Delimited) All the fields of the LOINC Table with each record on a separate line (terminated by CR/LF), and each field delimited by a comma character. The data files in this package are provided in the Comma Separated Value (CSV) format according to RFC 4180 and encoded with UTF-8. This package also contains basic scripts for loading the data into some popular databases (Oracle and MySQL for now). LOINC Users' Guide (this document) The LOINC Users’ Guide is the definitive document about LOINC and is available as a PDF file. It explains the structure of the table, its rationale, and the rules we used for naming test results. RELMA The Regenstrief Institute also produces a Windows-based mapping utility called the Regenstrief LOINC Mapping Assistant (RELMA®) to facilitate searches through LOINC and to assist efforts to map local codes to LOINC codes. This program is also available for free use. RELMA Users' Manual The definitive guide to using the RELMA program. All of the above files are available from the LOINC website at http://loinc.org. Additionally, Regenstrief provides a web-based search application available at http://search.loinc.org that can be used to search the latest version of LOINC right from your Internet browser. We welcome corrections or extensions to the database. We are not interested in adding terms that might be needed in some future situation but we are interested in adding test observations that are actively being reported today. Appendix D provides instructions for submitting new terms. Clem McDonald Chairman, LOINC Committee Chairman, Laboratory LOINC Committee Stan Huff Co-Chairman, LOINC Committee Chairman, Clinical LOINC Committee 3 LOINC® Users’ Guide - June 2016 Acknowledgments Over the years, LOINC has been supported financially by many organizations and individuals. We're thankful for the generous support from: • • • • • • • • • • • • • • Regenstrief Institute Regenstrief Foundation National Library of Medicine (Contracts NO1-LM-4-3510, N01-LM-6-3546, N01-LM-9-3517, and HHSN276200800006C, HHSN276201400138P, HHSN276201400239P) American Physical Therapy Association bioMérieux Indiana Clinical and Translational Sciences Institute California Healthcare Foundation Radiological Society of North America through the National Institute of Biomedical Imaging and Bioengineering AHIMA Foundation (Contract FORE-ASPE-2007-5) RTI International (Contract 0-312-0209853) John A. Hartford Foundation of New York Agency for Health Care Policy and Research (Grants HS 08750 and HS 07719-03) Centers for Disease Control and Prevention (Grant and Contracts R13/CCR517099 and H75/CCH520501) Members of the LOINC Community who have made donations or became Premium Members This work was initiated by and performed under the auspices of the Regenstrief Institute. We remain grateful to the late Dr. Henrik Olesen for his very helpful comments and insights about laboratory test coding. Dr. Olesen served as chair of the Commission on Nomenclature for Properties and Units (1989) and member of the joint IUPAC-IFCC Commission on Nomenclature, Properties and Units (1988-1997). 4 LOINC® Users’ Guide - June 2016 1 Introduction The goal of the LOINC project is to create universal identifiers (names and codes) used in the context of existing ASTM E1238, HL7, CEN TC251, and DICOM observation report messages employed in the various sub-domains of healthcare informatics such as Clinical Laboratory Information Management Systems and Computer-Based Patient Record Systems.9, 10 Specifically, the identifiers can be used as the coded value of the “Observation Identifier” field (# 3) of the OBX segment of an ORU HL7 (HL7 version 2.x or ASTM 1238-9410) messages, or in a corresponding field in future versions of these HL7 and DICOM standards. LOINC codes, identified in HL7 as code system “LN”, provide “universal” identifiers. When used in the context of messaging standards, LOINC codes allow the exchange of clinical laboratory data between heterogeneous computing environments. To facilitate this process, each identifier requires a fully specified name created in a standard way. This way, users can create long names for their tests that can be linked to the universal test identifier using semi-automated methods. We focused our initial effort on creating names for results of reportable tests or clinical measurements rather than request-able batteries, because the issues involved in naming results of tests are less complex than those involved in naming the batteries. However, we have also defined codes for some order panels. It is important to note that LOINC codes for single tests, reports, and observations are equally suitable for the ordered item in an order record or message, or as the result identifier in a result message. The LOINC database is a “universal” master file of standard “test” names and codes that will cover most of the entries in these files of operational laboratory systems, so that the terms in these operational master files could be mapped directly to universal codes and names. The names we create correspond most closely to the “long test descriptions” seen in test master files. The LOINC names are “fully specified” names. That is, if a person wanted to map her local test dictionary to the LOINC codes, all the information needed to map a local test name to one of the fully specified names should be present in the LOINC name. We aim to achieve a level of detail in the definition of a test that will map one-to-one to the separately reported observations on a clinical laboratory report. If a test has its own column on a clinical report, or has a reference range that is significantly different from other tests, or has a different clinical meaning than other related tests, it will usually be assigned a separate LOINC code and name. We deliver these fully specified names, their codes, and their related names as a database in which each line corresponds to a unique test measurement. 1.1 Successes The LOINC codes have been greeted enthusiastically since they were released to the Internet in April of 1996. Today, LOINC has been adopted widely. It is used in settings of all kinds, from clinical institutions to health systems, IT vendors, research projects, government agencies, and international e-Health projects spanning many countries. There are now more than 44,300 users in 172 different countries. LOINC adoption worldwide has steadily accelerated. We are now adding more than 600 new users per month. Many countries have adopted LOINC as a national standard, including Australia, Brazil, Canada, Cyprus, 9 10 McDonald CJ, Tierney WM. Computer-stored medical records. JAMA 1988;259:3433-40. Dick AS, Steen EB (editors). The computer based patient record. Washington DC: National Academy Press; 1991. 5 LOINC® Users’ Guide - June 2016 Estonia, France, Germany, Mexico, Mongolia, the Netherlands, Rwanda, Thailand, Turkey, and the United States. There are large-scale health information exchanges using LOINC in Hong Kong, Italy, the Philippines, Spain, Singapore, and Korea as well. The LOINC content and associated documentation have been translated into many languages. We have developed a mechanism to make the process more efficient for our translators by using the atomic parts that a term is composed of. Both RELMA and the online LOINC search application (http://search.loinc.org) now have multilingual searching capabilities. We have described how our approach to translations supports international adoption,11, and we highlight the work of our international colleagues in a special section on the LOINC website at http://loinc.org/international. We provide a voluntary directory of organizations that have adopted LOINC on our website (http://loinc.org/adopters) and give news updates on domestic and international adoption at our meetings. 1.2 What is not part of the name Certain parameters and descriptions pertaining to test performance are specifically excluded from the fully specified test name. These parameters will typically be reported in separate fields (attributes) of a test/observation report message, not as part of the observation name. Attributes that we explicitly exclude from the fully specified name are: • • • • • • the instrument used in testing fine details about the sample or the site of collection such as “right antecubital fossa” the priority of the testing, e.g., whether stat or routine who verified the result the size of the sample collected the place of testing (e.g., home, bedside, clinical lab) In the case of laboratory tests, the name does include information that identifies the type of sample (or specimen). However, the “sample” part of the name is not meant to carry all possible information about the sample, but only enough to indicate significant differences in the result and to reflect current usage in test names. For example, laboratories usually define urine sodium, sweat sodium, and serum sodium as different tests because each of these has a different normal range. But laboratories do not define different tests to distinguish the concentration of arterial serum sodium from venous serum sodium, though the lab may report that the sample was venous or arterial in another part of the report. We are guided by the pragmatics of conventional usage. If laboratories define separate tests for the same measurements done on different specimens (this usually implies a well-defined normal range difference), we will define different “result-able” tests in our dictionary. If they do not, we will not. The extent to which we include methods as part of the name is also guided by pragmatics. We distinguish tests/observations by the type of method used to produce the results only if a given type of method has an important effect on the interpretation of the result. This is a complex subject and it is difficult to fully describe our rationale in this guide. Where laboratories do not tend to include the method in the name (e.g., most of chemistry) we do not include the method in the name. Where they tend to (e.g., in immunochemistry) we do. For some tests, this can be justified by the standardization of methods to produce “equivalent” results, and sometimes by the many variables (method, reagent) that one could never hope to represent fully in a single name. However, even when we do distinguish these cases, we distinguish by type of method, not the most detailed possible method distinction. (See section 2.7, Type of Method, for more details.) 11 Vreeman DJ, Chiaravalloti MT, Hook J, McDonald CJ. Enabling international adoption of LOINC through translation. J Biomed Inform. 2012 Aug;45(4):667-73. doi: 10.1016/j.jbi.2012.01.005. Epub 2012 Jan 21. PubMed PMID: 22285984; 6 LOINC® Users’ Guide - June 2016 The College of American Pathologists produces statistical summaries of the results for measurements of standard samples broken down by laboratory and by instrument or procedure. (These are called CAP surveys.) We considered using this CAP survey data to decide empirically when test names should be distinguished by method, but decided this was not feasible because many of the apparent differences in method obtained with the standard samples were artifacts of the sample matrix and did not apply to serum specimens. In addition, the variation among laboratories was often of the same magnitude as the variation among methods within laboratories for the same method. We do not mean to underrate the importance of method differences. The result message will still include information about the normal range for that particular test, the source laboratory and, if the laboratory wishes, specific information about the method. However, such information is reported in separate fields in the HL7 message (e.g., OBX-17 can carry very detailed method information). It is not embedded in the names of the test. 1.3 Scope of LOINC The current scope of the existing laboratory portion of the LOINC database includes all observations reported by clinical laboratories, including the specialty areas: chemistry, including therapeutic drug monitoring and toxicology; hematology; serology; blood bank; microbiology; cytology; surgical pathology; and fertility. A large number of terms used in veterinary medicine have also been included. In addition, the scope includes those non-test measurements that are commonly required to interpret test results and are usually included as part of the report with the laboratory observations. Examples include: • • • • for cervical pap smears, the phase of menstrual cycle or use of estrogens for arterial blood gases, inspired oxygen for drug concentrations used in pharmacokinetics, the dose for a blood bank, the number of units dispensed The June 2000 release contained our first foray into order sets/batteries. Existing LOINC codes could always be used to order the specific tests observation, but prior to 2000 there was no mechanism to use LOINC codes to order a set of observations. We have currently only addressed a group of observations that are either naturally produced as a panel (e.g., urinalysis) or are defined by some national body. For example, the Basic metabolic 2000 panel that was defined by HCFA (which is now CMS). The clinical portion of the LOINC database covers tests, measures, and other observations about a patient that can be made without removing a specimen from them. LOINC has codes for observations like vital signs, hemodynamics, intake/output, EKG, obstetric ultrasound, cardiac echo, urologic imaging, gastroendoscopic procedures, pulmonary ventilator management, radiology studies, clinical documents, selected survey instruments (e.g. Glasgow Coma Score, PHQ-9 depression scale, CMS-required patient assessment instruments), and other clinical observations. 1.4 The LOINC Code Identifier To each name, we have assigned a unique permanent code that we call the LOINC code. This is the code that systems should use to identify test results in electronic reports. The LOINC code has no intrinsic structure except that the last character in the code is a mod 10-check digit. The algorithm to calculate this check digit is given in Appendix C. All of the structure associated with a single LOINC entity is stored in other fields in the LOINC database. 7 LOINC® Users’ Guide - June 2016 2 Major “Parts” of a Test/Observation Name The fully specified name of a test result or clinical observation has five or six main parts including: the name of the component or analyte measured (e.g., glucose, propranolol), the property observed (e.g., substance concentration, mass, volume), the timing of the measurement (e.g., is it over time or momentary), the type of sample (e.g., urine, serum), the scale of measurement (e.g., qualitative vs. quantitative), and where relevant, the method of the measurement (e.g., radioimmunoassay, immune blot). These can be described formally with the following syntax. <Analyte/component>:<kind of property of observation or measurement>:<time aspect>:<system (sample)>:<scale>:<method> The colon character, “:”, is part of the name and is used to separate the main parts of the name. The first part of the name can be further divided up into three subparts, separated by carats (^). The first subpart can contain multiple levels of increasing taxonomic specification, separated by dots (.). The third and fourth parts of the name (time aspect and system/sample) can also be modified by a second subpart, separated from the first by a carat. In the case of time aspect, the modifier can indicate that the observation is one selected on the basis of the named criterion (maximum, minimum, mean, etc.); in the case of system, the modifier identifies the origin of the specimen if not the patient (e.g., blood donor, fetus, and blood product unit). The hierarchical structure is outlined in Table 1, with references to the section numbers where each item is explained in detail. Table 1: Hierarchical Structure of Fully Specified Analyte Names Subpart Name Section Component/analyte 2.2 Name and modifier 2.2.1 Component/analyte name 2.2.1.1 Component/analyte subname 2.2.1.2 Component/analyte sub-sub-name 2.2.1.3 Information about the challenge (e.g., 1H post 100 gm PO challenge) 2.2.2 Adjustments/corrections 2.2.3 Kind of Property (mass concentration, mass) 2.3 Time Aspect (point or moment in time vs. time interval) 2.4 System/Sample type (urine, serum) 2.5.1 “Super System” (patient, donor, blood product unit) 2.5 Type of Scale (nominal, ordinal, quantitative) 2.6 Method Type 2.7 We used Tietz12, Henry13, IUPAC14, EUCLIDES15, diagnostic microbiology textbooks, such as Mahon and Manuselis16, the American Association of Blood Banking17, and other sources as well as the expertise 12 13 Ibid. Henry JB. Clinical Diagnosis and Management by Laboratory Methods. Philadelphia:W.B. Saunders; 1994. 14 International Union of Pure and Applied Chemistry/International Federation of Clinical Chemistry. The Silver Book: Compendium of terminology and nomenclature of properties in clinical laboratory sciences. Oxford: Blackwell Scientific Publishers; 1995. 15 Euclides Foundation International. EUCLIDES Laboratory Investigation Codes. Available from Dr. Georges DeMoor, Euclides Foundation International nv, Excelsioriaan 4A, B-1930, Zaventern, Belgium. Phone: 32 2 720 90 60. 16 Mahon CR, Manuselis G (editors). Textbook of Diagnostic Microbiology. Philadelphia:W.B. Saunders; 1995. 17 Walker RH. American Association of Blood Banks Technical Manual. 11th ed. Bethesda, MD: Amer Assoc of Blood Banks, 1993. 8 LOINC® Users’ Guide - June 2016 of the individuals or the committee to choose preferred names. Examples of fully specified LOINC names: Sodium:SCnc:Pt:Ser/Plas:Qn Sodium:SCnc:Pt:Urine:Qn Sodium:SRat:24H:Urine:Qn Creatinine renal clearance:VRat:24H:Ur+Ser/Plas:Qn Glucose^2H post 100 g glucose PO:MCnc:Pt:Ser/Plas:Qn Gentamicin^trough:MCnc:Pt:Ser/Plas:Qn ABO group:Type:Pt:Bld^donor:Nom Body temperature:Temp:8H^max:XXX:Qn Chief complaint:Find:Pt:^Patient:Nar:Reported Physical findings:Find:Pt:Abdomen:Nar:Observed Binocular distance:Len:Pt:Head^fetus:Qn:US.measured 2.1 General naming conventions 2.1.1 Abbreviations in names of component/analyte Except for enumerated exceptions (Table 2), abbreviations should not be used in the component (analyte) of the name. We require the use of “total”, not “tot”, “fraction”, not “frac”, “Alpha”, not “A-,” “Beta” not “B-” (and so on for any Greek letter), “oxygen”, “not O2”, and so on. Table 2: Example Component Abbreviations Abbreviation 2.1.2 2.1.2.1 Full Name Ab Antibody Ag Antigen DNA deoxyribonucleic acid HIV Human immunodeficiency virus HLA human histocompatibility complex derived antigens HTLV I Human t-cell lymphotropic virus-I Ig “X” immunoglobulins (e.g., IgG for immunoglobulin G, IgM for immunoglobulin M) NOS not otherwise specified RNA ribonucleic acid rRNA ribosomal ribonucleic acid General naming rules for the component (analyte) part of the fully specified name. Place the identifier of the substance being measured first. This means “Hepatitis A antibodies (Ab)”not “Antibodies, Hepatitis A.” 9 LOINC® Users’ Guide - June 2016 2.1.2.2 Use the generic name of a drug, not the brand name, when referring to drug concentrations and antimicrobial susceptibilities, e.g., Propranolol, not Inderal. We will usually include the brand or trade names in the related names (synonyms) field. 2.1.2.3 Use full taxonomic name of an organism or virus name (not the disease) when describing a test that diagnoses that disease. Say “Rickettsia rickettsii Ab” not “Rocky Mountain spotted fever Ab”. Say “herpes simplex virus Ab” not “HSV Ab.” The disease name should be included as a synonym in the related name field. 2.1.2.4 Species and groups of species: SP identifies a single species whose identity is not known. SPP identifies the set of species beneath a genus. We have a third case, however. In some tests, antibodies apply to different strains of species. In rickettsial diseases, the antibodies are then against groups of species, e.g., the spotted fever group or the typhus group. In this case we use Rickettsia spotted fever group and Rickettsia typhus group. 2.1.2.5 When tests include the name of a bacterium (e.g., Neisseria gonorrhoeae DNA probe) for the formal LOINC name we use the full bacterial name from the International Journal of Systematic and Evolutionary Microbiology18. When it includes the name of a virus (e.g., West Nile Virus IgM antibodies), we use the viral name as given by Index Virum19. 2.1.2.6 When the test measures an antigen to a specific species of organism but cross-reactivity is such that other organisms are identified, the name should be the principal organism that is targeted by the test. 2.1.2.7 Avoid “direct” and “indirect” except as parts of synonym names. Avoid “conjugated” and “unconjugated” when a more precise term, such as “glucuronidated” or “albumin-bound” is available. 2.1.2.8 Use “platelets”, not “thrombocytes.” 2.1.2.9 Name vitamins by the chemical name. For example, use thiamine not Vitamin B1, The name containing “Vitamin” will be included as a synonym. This is the only reasonable approach because all vitamins have a chemical name but not all vitamins have a “numbered” vitamin name. One exception to this rule is that we will use the widely accepted vitamin name for nutrition intake terms. 2.1.2.10 Always specify whether serology tests measure the antigen or antibody, using the abbreviation “Ab” for antibody and “Ag” for antigen. Remove the “anti” from “ANTI X Ab.” It is redundant and obscures the most significant word in the name. Thus, “anti-smooth muscle Ab” becomes “Smooth muscle Ab.” Common abbreviations or shortened names, e.g., ANA for anti-nuclear antibody, will be found in the related names field. 2.1.2.11 VDRL will be named Reagin Ab because that is what it is. We will have to depend upon synonyms and aliases to equate our “standardized” names with the old names. 2.1.2.12 Use the noun form of the target of the antibody, e.g., Myocardium Ab, not Myocardial Ab. 18 Euzéby JP. List of bacterial names with standing in nomenclature: a folder available on the internet. Int J Syst Bacteriol 1997;47:590592. (List of prokaryotic names with standing in nomenclature. [Update 2008 May 2, cited 2008 June]. Available from: http://www.bacterio.net ). 19 Index Virum, [Internet]. New York: New York, Catalogue of Viruses Version 2, based on the 6th ICTV Report; c2002 [Updated 2007 July; cited 2008 June]. Available from: http://phene.cpmc.columbia.edu/ . 10 LOINC® Users’ Guide - June 2016 2.1.2.13 Anion vs. acid: Always use the anionic name for chemicals, not the acid name, e.g., lactate, citrate, and urate, not lactic acid, citric acid, and uric acid. The acid form of the name will be included in the related names field of the database. 2.1.2.14 Alcohols: Always use the single-word names for alcohols: methanol, not methyl alcohol; ethanol, not ethyl alcohol, and so on. 2.1.2.15 Always spell out OH as Hydroxy, or as - ol, with no space or hyphen between Hydroxy and the next word. 2.1.2.16 Greek letters, alpha, beta, gamma, etc., are always spelled out (e.g., alpha tocopherol, not A- tocopherol), with a space between the spelled out Greek letter and the rest of the chemical name 2.1.2.17 Use pH, not log (H+). 2.1.2.18 Whenever possible, the component will contain the scientific names of allergens. NOTE: This is a convention implemented in January 2002. 2.1.2.19 Avoid use of the word “total” in laboratory test names, except when denoting the denominator of a fraction. Thus it is Alkaline phosphatase, not Alkaline phosphatase.total, but Alkaline phosphatase.bone/Alkaline phosphatase.total. 2.1.2.20 For drug metabolites, we will use the “nor” form rather than “desmethyl”, e.g., for instance nordoxepin not desmethyldoxepin. 2.1.3 Punctuation in analyte names A number of analyte names include punctuation characters such as commas, for example, to identify the position of multiple alkyl groups in a carbon chain. We will avoid special characters, e.g., commas, dashes, and parentheses, except where they are included in the name specified by IUPAC, the Chemical Abstract Service (CAS) convention, or another international convention. So for example, commas will appear in multiple substitutions of alkyl chains per the CAS standard, dashes, asterisks and colons will appear in HLA allele names, colons will appear in the names of some microorganisms, and parentheses (i.e., round brackets) will appear in the names of red blood cell antigens. 2.1.4 Case insensitivity All names are case insensitive. Prior to December 2006, we used upper case in the database and our examples, but change to mixed case for easier readability. In electronic messages senders and receivers can use upper, lower or mixed case. However, the meanings should not be sensitive to case conversions to avoid any possibility of confusion when the information is sent over networks that may apply case conversion. To identify parts of the few names that by international convention are case sensitive, such as red blood cell antigens, we use the word “little” in front of the letter that is lower case. We use a similar convention to indicate superscripts with the word SUPER. See examples in Table 3. Table 3: Example Case Specifying Conventions Standard mixed case Our conventions L little u super little a Lua little i-1 subtype i-1 Subtype 11 LOINC® Users’ Guide - June 2016 2.1.5 Roman numerals vs. Arabic numerals Whenever possible, numerals shall be represented in their Arabic form. However, when the conventional name uses Roman numerals, as is the case for clotting factors such as factor VIII, the LOINC primary name will use Roman numerals and we define a synonym containing Arabic numerals. 2.1.6 Exponents We will use the phrase “exp” to indicate an exponent in the Component. According to the Unified Code for Units of Measure (UCUM), exponents are typically represented using an asterisk (*) or carat (^). However, asterisks and carats both already have defined meanings in the LOINC. (As described later, asterisks are used in variables that report another specific part of the LOINC name, and carats are used as delimiters of subparts). For this reason, we use “exp” to avoid ambiguity. For example, the concept “height raised to the power of 2.7” is represented as “height exp 2.7”. 2.2 Component/analyte (1st part) The first main part consists of three subparts: (1) the principal name (e.g., the name of the analyte or the measurement); (2) the challenge or provocation, if relevant, including the time delay, substance of challenge, amount administered, and route of administration; and (3) any standardization or adjustment. The three subparts of the first part follow this syntax: <[analyte].[subclass].[sub-subclass]> ^ <[time delay] post [amount] [substance] [route])> ^ <adjustment> In the above syntax, the carat (^) is a required delimiter and the “dot” (.) separates the analyte name from its subspecies. This convention also implies that dots (.) and carats (^) cannot be a formal part of any of the words that are connected by these delimiters. These subparts are described in greater detail below, Sections 2.2.1 through 2.2.3. 2.2.1 Analyte Name (1st subpart) The first subpart names the analyte, including any relevant sub-classifications, separated from the main analyte name by dots. 2.2.1.1 Analyte/Subclass The principal name (the first subpart) can be divided further by subclass (e.g., Calcium by itself is one component, Calcium.ionized names another test that measures a subclass of calcium.) Subclasses are separated by dots. Examples of common subclasses include: bound, free, and bioavailable; ionized and non-ionized; glycated; glucuronidated and non-glucuronidated; IgA, IgD, IgE, IgG, and IgM as modifiers indicating the subspecies of antibodies. Note that bio-available is distinguished from free by including both free and partially bound moieties. 12 LOINC® Users’ Guide - June 2016 If the antibody is from a particular subclass of antibodies specify the type of immunoglobulin (IgM, IgG, IgA, or IgD) e.g., Hepatitis A virus Ab.IgG, Hepatitis A virus Ab.IgM. If more than one subclass of immunoglobulin is included in the measurement, all are listed in the subclass, e.g., “Mumps virus Ab.IgG+IgM” with a plus sign (+) to separate the subspecies. There should be no spaces between the plus sign and the words it connects. If two or more constituents are measured as one quantity, each constituent should be named and the component separated by a plus sign, e.g., Cyclosporine+metabolites or Human papilloma virus 16+18+31+33+35+45+51+52+56 DNA. If multiple analytes are measured separately, the analytes are separated by an ampersand (&) surrounded by spaces. Two cases that use the ampersand convention are the names of panel terms and impression terms. The naming of panel terms is described more completely in Section 8, but here we describe its use of ampersand. The enumerated child elements of a panel are each measured individually, so we often use ampersand in the name of the parent term (the panel term), e.g., ABO & Rh group panel. This particular example of ABO & Rh group also illustrates how panel terms using ampersand are different than an observation term with ampersand. The ABO & Rh group panel is linked to two separate observation codes, one for ABO and another for Rh group, that each carries its own result. An ABO & Rh group observation term would carry a combined (but separately measured) result (e.g. A positive). Either term could be used in ordering, depending on the reporting approach. Impressions terms may also use ampersand, for example, Hepatitis A virus Ab.IgM & total impression. In the case of the Hepatitis antibody impression, both the IgM antibody and the total impression are described separately. In some cases, panel or impression Components contain both a plus sign (+) and an ampersand (&), for example, Human papilloma virus 16 & 18 & 31+33+35+39+45+51+52+56+58+59+66+68 DNA impression. In this example, the HPV 16 and HPV 18 impressions are both described separately, as is the impression for the group HPV 31+33+35+39+45+51+52+56+58+59+66+68, which group is measured as a single quantity. 2.2.2 Challenge test (2nd subpart) The second subpart contains information necessary to interpret “challenge” (or loading or tolerance) tests. Variables that report the result of a measurement taken a certain amount of time post challenge (e.g., glucose after an oral glucose tolerance test) must be distinguished according to the challenge and the time post challenge. Thus, the second subpart has a substructure that identifies the time interval or time difference and the challenge, using the following syntax, where the word “post” (or base line) is required. <time delay> “post” <challenge> where the challenge can be further characterized as <amount given> <substance/treatment given> <route given> An example of a challenge that used all parts would be: Aldosterone^1H post 25 mg captopril PO The time difference follows the syntax: n<S|M|H|D|W> where n is a number (possibly a decimal); S denotes seconds; M denotes minutes; H denotes hours; D denotes days; and W denotes weeks. The time delay can be preceded by a 'greater than' (>) sign, e.g., >4H. Table 4 lists some possible values for time difference, but any time specification that follows the above syntax would be legal. 13 LOINC® Users’ Guide - June 2016 In addition to specifying a time elapsed since challenge, the time delay slot can be used to name a clock time when the measurement was taken, e.g., Glucose^10 AM specimen, or to specify the ordering of specimens, e.g., ^1st specimen, ^2nd specimen. Use this syntax to indicate pre- and post-immunization specimens, acute and convalescent specimens, or a series of specimens for which no more detailed information is available. Table 4: Example Time Delay Post Challenge BS Baseline (time just before the challenge) PEAK The time post drug dose at which the highest drug level is reached (differs by drug) TROUGH The time post drug dose at which the lowest drug level is reached (varies with drug) RANDOM Time from the challenge, or dose not specified (random) n minutes/hours/days/weeks/months/etc. after challenge begun: 1M 1 minute post challenge 6H 6 hours post challenge 2M 2 minutes post challenge 7H 7 hours post challenge 3M 3 minutes post challenge 8H 8 hours post challenge 4M 4 minutes post challenge 8H SHIFT 5M 5 minutes post challenge 12H 12 hours post challenge 6M 6 minutes post challenge 24H 24 hours post challenge 7M 7 minutes post challenge 2D 2 days 8M 8 minutes post challenge 3D 3 days 9M 9 minutes post challenge 4D 4 days 10M 10 minutes post challenge 5D 5 days 15M 15 minutes post challenge 6D 6 days 20M 20 minutes post challenge 7D 7 days 25M 25 minutes post challenge 1W 1 week 30M 30 minutes post challenge 10D 10 days 1H 8 hours aligned on nursing shifts 1 hour post challenge 2W 2 weeks 1½ hour (90 min) post challenge 3W 3 weeks 2H 2 hours post challenge 4W 4 weeks 2.5H 2½hours post challenge 1MO 1 month (30 days) post challenge 3H 3 hours post challenge 2MO 2 months (60 days) post challenge 4H 4 hours post challenge 3MO 3 months (90 days) post challenge 5H 5 hours post challenge 1.5H The second subpart is also used to describe measurements taken at a specified point after the beginning of an ongoing treatment, such as peritoneal dialysis, e.g., Creatinine^12H post peritoneal dialysis. More generally, this syntax can be used to indicate that observations were recorded, e.g., ^post partum, ^postoperative, or ^post EDTA therapy. The syntax of the second subpart can be specified in various ways to indicate challenges of greater or lesser specificity, corresponding to the amount of detail that the laboratory knows about the challenge specimen. 14 LOINC® Users’ Guide - June 2016 Examples of the range of possibilities include: Table 5: Example Challenge Subparts “^” Time “Post” Amount Sub/Treat Route 11-Deoxycortisol ^ 8H Metyrapone PO ^ 45M post post 30 mg/kg Corticotropin dose u/kg Insulin Ascorbate ^ post dose 11-Deoxycortisol ^ 2ND specimen post XXX challenge 17-Hydroxyprogesterone ^ 6H post XXX challenge 11-Deoxycortisol ^ post XXX challenge Calcium ^ post CFst C peptide ^ post CFst Analyte 12H IV PO We denote the route of the challenge by HL7 Version 2.3 “abbreviations for medication routes” (Table 6). An oral route of administration would be denoted by “PO,” 20an intravenous route by “IV.” Table 6: Example Route Abbreviations for Challenge Part (from HL7 v.2.3, Chapter 4) Challenge Description Abbr. Abbr. Challenge Description AP Apply Externally MM Mucus Membrane B Buccal NS Nasal DT Dental NG Nasogastric EP Epidural NP Nasal Prongs ET Endotrachial Tube NT Nasotrachial Tube GTT Gastronomy Tube OP Ophthalmic GU GU Irrigant OT Otic IMR Immerse (Soak) Body Part OTH Other/Miscellaneous IA Intra-arterial PF Perfusion IB Intrabursal PO Oral IC Intracardiac PR Rectal Intracervical (uterus) RM Rebreather Mask Intradermal SD Soaked Dressing Inhalation SC Subcutaneous Intrahepatic Artery SL Sublingual ICN ID IH IHA IM Intramuscular IN Intranasal TRH TP IO Intraocular TRA IP Intraperitoneal Thyrotropin-releasing hormone Topical Tracheostomy TD Transdermal IS Intrasynovial TL Translingual IT Intrathecal UR Urethral IU Intrauterine VG Vaginal IV Intravenous VM Ventimask MTH Mouth/Throat WND Wound 20 In the United States, PO (an abbreviation for per ora) is used to identify medications taken by mouth. 15 LOINC® Users’ Guide - June 2016 Examples: Glucose^30M post 100 g glucose PO:MCnc:Pt:Ser/Plas:Qn Gentamicin^trough:MCnc:Pt:Ser/Plas:Qn For drug peak (obtained at a time presumed to reflect the highest concentration) and trough (obtained at a time presumed to reflect the lowest concentration) measures, the nature of the substance loaded is the same as the analyte name, and need not be included. Reporting the baseline measure as part of a challenge test 2.2.2.1 Through LOINC release 2.52, we have defined one baseline term for different challenge batteries when the challenge is given by the same dose and route. For example, we define one baseline serum glucose for the 100 gm oral glucose tolerance test regardless of the number of separate measurements defined in the battery: Glucose^pre 100 g glucose PO A laboratory could use this same test identifier to identify the baseline result of a two hour glucose tolerance and a three hour glucose tolerance, for example. However, the number and variety of challenges have been rapidly increasing. Over time it appears impractical to create a baseline term for every dose and route combination. Furthermore, baseline measurements are not affected by the subsequent challenge and could in principle be reported simply as the “unadorned” measurement with no named relation to a coming challenge. Therefore, we are considering creating only generic baseline “pre challenge” terms, for example, Glucose^pre challenge. The specifics of the challenge would be reported elsewhere. This proposed approach is an ongoing point of discussion, and the terms in LOINC release 2.52 follow the original model. Physiologic challenges 2.2.2.2 Some challenges are defined in terms of a physiologic stress, not a dose of a chemical substance. The LOINC names currently cover calorie fasts (no calorie intake), exercise, and fluid restrictions. These challenges are denoted by codes given in Table 7. In the case of such challenges, the syntax also includes the duration of the challenge. For example: post <duration><physiologic challenge> Triglyceride^post 12H CFst Table 7: Example Nature of Challenge Type Description CFst Calorie fast. No caloric intake (food) for the period specified in the time part of the term, e.g., POST 12H CFst Exercise Exercise undertaken as challenge (can be quantified) FFst Fluid “fast.” No fluid intake for the period specified 16 LOINC® Users’ Guide - June 2016 The naming structure is an exact analogous structure to that of chemical challenges. A test for glucose after 12 hours of an energy fast would be represented as: Glucose^post 12H CFst:MCnc:Pt:Ser/Plas:Qn A test for osmolality after a 12-hour fluid restriction would be: Osmolality^post 12H FFst:Osmol:Pt:Urine:Qn A test for triglyceride after 12-hour energy fast would be: Triglyceride^post 12H CFst:MCnc:Pt:Ser/Plas:Qn Two durations can appear in one specification, for example: Cortisol^1.5H post 0.05-0.15 U insulin/kg IV post 12H CFst:MCnc:Pt:Ser/Plas:Qn Our rules for naming challenge tests work well only when there is a single intervention followed by a test for one or more components over time. Complex challenge tests involving more than one intervention or complicated sampling techniques need a unique name, but the name may not provide a complete description of all of the test parameters. 2.2.2.3 Reporting characteristics of challenge as separate observations Because we cannot anticipate every type of challenge and route of administration, and because some challenge tests have no usual dose, some challenge tests will not contain a dose. Challenge observations that do not include a specific dose in the name have the word “dose” where a numeric dose would otherwise appear. The general form is: <analyte>^<time> post dose <route> Examples: Glucose^1H post dose insulin IV:MCnc:Pt:Ser/Plas:Qn The actual dose might then be sent as a comment or as a separate “test” that carries the dose as its value. To accommodate laboratories that wish to transmit the relevant challenge dose as a separate observation, we also define separate test names (and codes) for reporting such doses. This dose could then be sent by the reporting service as a separate result in a separate OBX segment. The name of the observation that identifies the value of the dose would have the form: <drug or challenge substance>: <time> post dose <challenge substance> Examples: Glucose.PO:Mass:Pt:Dose:Qn Gentamicin:Mass:Pt:Dose:Qn Thus we distinguish a drug concentration from the drug dose by means of the system (sample), 4th part, of the test name (see Section 2.5). You can find the observations that carry the dose of drugs or challenges grouped in the class DRUGDOSE in the LOINC database. This approach has the advantages of parsimony and practicality. It also provides an observation ID for the piece of information that must be 17 LOINC® Users’ Guide - June 2016 transmitted along with the request for the observation. Another example would be: Oxygen:PPres:Pt:BldA:Qn Oxygen inhaled:VRat:Pt:Inhl gas:Qn (liters/minute or milliliters/second) Oxygen inhaled mechanism:Type:Pt:Dose:Nom (to report kind of delivery mechanism, e.g., nasal cannula) An analogous approach is used for reporting many kinds of associated variables when the variables are not conventionally embedded in the name. We take this approach in part because there are too many levels of the variables and it is not feasible to represent them all. 2.2.2.4 Generic challenge specifications We allow for a range of specificity regarding challenges from fully specified to very generic. Some challenges will be specified fully as described above, e.g., ^30M post 100 g glucose PO. We will also include: challenges without the amount specified, e.g., ^30M post dose glucose; those that specify a time elapsed but not a particular challenge, e.g., ^1H post XXX challenge; those that do not specify the exact time but provide ordering information, e.g., ^2nd specimen post XXX challenge; or even more generic, ^ post XXX challenge. These latter variants are needed to accommodate challenges that do not fit any common protocol, or referrals to reference laboratories where the study protocol is not reported. 2.2.2.5 Acute and convalescent, pre and post immunization To assess the efficacy of immunizations, we measure antibody levels before and after the immunization; similarly, we obtain evidence for acute infection by assessing acute and convalescent screens. Both of these cases are reported with the 1st specimen, 2nd specimen syntax, for example: Acute specimen, 1st specimen, pre-immunization specimen: Streptococcus pneumoniae Ab.IgG^1st specimen:ACnc:Pt:Ser:Qn Convalescent specimen, 2nd specimen, post-immunization specimen: Streptococcus pneumoniae Ab.IgG^2nd specimen:ACnc:Pt:Ser:Qn 2.2.3 Adjustments/corrections (3rd subpart) The third subpart of the data element contains calculations that adjust or correct some measured value. We use this subpart to distinguish corrected or adjusted values from the uncorrected measurement, e.g., corrected cell counts from the raw cell counts. Since these attributes are unique to each measurement, they will be short phrases of text rather than a controlled vocabulary to define the content of the third subpart. However when defined, such a test will have a unique LOINC code and the meaning will be fixed by the text in the third part. Examples: Calcium.ionized^^adjusted to pH 7.4:SCnc:Pt:Ser/Plas:Qn Leukocytes^^corrected for nucleated erythrocytes:NCnc:Pt:Bld:Qn 18 LOINC® Users’ Guide - June 2016 2.2.4 Distinguishing multiple values for any test via the test name (4th subpart) HL7 messaging allows for multiple results for one observation. Some systems, however cannot distinguish separate answers per observation, so they made the test names like organism 1, organism 2 or substance 1, substance 2 to report multiple organisms or substances identified in samples. We do not encourage this type of reporting because that distinction can more clearly be accomplished by using one test name (e.g., organism identified) and the HL7 sub ID to distinguish the multiple organisms/substances. However, we have created a few terms to accommodate systems that bind the distinction into their test names. The fourth subpart of the component name will allow reporting of repeat observations taken at the same time and/or on the same specimen. Example: Bacteria identified^^^2:Prid:Pt:Stool:Nom:Culture 2.3 Kind of Property (also called kind of quantity) (2nd part) The second part of the fully specified name distinguishes between different kinds of quantities relating to the same substance, e.g., the mass concentration versus the substance (molar) concentration of sodium in a urine sample, or the absolute eosinophil count versus the percent of the total white count that is made up of eosinophils. The type of property (kind of quantity) is an IUPAC concept described in the Silver Book21. We include most of the relevant IUPAC types of property in the LOINC properties table. (See Table 8 for more examples.) Main property categories Mass: Observations reported with mass (milligrams, grams, etc.) in the numerator of their units of measure have properties that begin with the word mass: mass content, mass concentration, etc. Substance: Observations reported with moles or mill equivalents in the numerator of their units of measure have properties that begin with the word substance. Catalytic activity: Observations that report enzymatic activity have properties that begin with catalytic, e.g., catalytic concentration, catalytic content. Arbitrary: Results that report arbitrary units in the numerator of their units of measure have a property that begins with arbitrary. Number: Counts are associated with properties that begin with number, e.g., a white blood cell count reported as number of WBCs divided by volume of blood, would have a property of Number Concentration. The pharmaceutical industry has the need for laboratory terms that are not specific as to whether the test measures a substance (substance concentration or substance rate) or mass (mass concentration or mass rate). We have created terms with the properties of MSCnc or MSRat to represent these more general test observations. By default, both RELMA and the online search application (http://search.loinc.org) hide these terms from the search results, but they can be displayed by adjusting the search limit settings in these programs. 21 International Union of Pure and Applied Chemistry/International Federation of Clinical Chemistry. The Silver Book: Compendium of terminology and nomenclature of properties in clinical laboratory sciences. Oxford: Blackwell Scientific Publishers; 1995. 19 LOINC® Users’ Guide - June 2016 Category subtypes: Each of the above major property categories has number of derivatives: concentration, content, ratio, fraction, and rate (See LOINC properties table). Concentrations: An amount divided by a volume. These have units such as mg/dL, or gm/L. Contents: An amount divided by a mass. These have units such as mg/gm sample or mg/total protein. Ratios: When a result is reported as one measure divided by another taken from the same system, the property is a ratio. The ratio of the mass concentration of substance A divided by the mass concentration of creatinine in a urine sample, for instance, is a mass ratio (MRto). The numerator and denominator of a ratio must come from the same system. If the measures come from different specimens, e.g., PT patient/PT control or creatinine serum vs. creatinine urine, it is a relative ratio (RelRto). The ratio of times coming from an actual and normal control (as in some coagulation tests) will be relative time (RelTime), a ratio of mass concentrations coming from two different specimens will be relative mass concentrate (RelMCnc), and a ratio of catalytic concentrations from different specimens will have the property of relative catalytic concentrate (RelCCnc). Fractions: Fractions are ratios of a part over a whole: Creatine kinase.MB/Creatine kinase.total, if measured in grams, is a mass fraction (MFr). Fractions are usually reported as percent. In Canada and other countries, fractions are measured as pure decimal fraction. For instance, a 95% O2 saturation would be resulted as 0.95. For some analytes, both styles of reporting are used in Canada, so we were asked to distinguish decimal fractions from pure fractions. Beginning with the June 2012 release, we now include terms that have “.DF” appended to the existing fraction properties. For example, some terms now have properties of “MFr.DF”, “SFr.DF”, “VFr.DF”, etc. Because of the confusion that occurs in countries that report results as both decimal fraction and percent, these properties were created to represent decimal fractions that are reported without units. Rates: A rate is a measure per a time period, e.g., mg/day would be a mass rate (MRat). Clearances have the property of volume rate, but “Clearance” will be included in analyte name to clarify meaning, e.g., Sodium renal clearance:VRat:24H:Urine:Qn Some measures do not fit the above schema. For instance, IUPAC describes an entitic quantity. This refers to measure per entity (e.g., cells, receptors, and molecules). Entitic quantities usually have units that include the name of some entity, e.g., red blood cells (“per 106 RBCs”). One must be careful when mapping measures of constituents of red blood cells to LOINC code because they can be expressed many ways, e.g., as an amount “per mass of hemoglobin”, “per liter of blood” or “per red blood cell”. The first is a mass content, the second a mass concentration, and the last is an entitic mass (mass per entity) — all different properties. Some tests report the name of an organism (or initially report the presence of any organism, and later identify the particular strain), toxic substance, antibody or antigen, as a test result. Use “Prid” (presence or identity) as the type of property field for results of this sort. Examples: Bacteria identified:Prid:Pt:Isolate:Nom:Bacterial subtyping Barbiturates positive:Prid:Pt:Urine:Nom:Confirm 20 LOINC® Users’ Guide - June 2016 ACnc means the number of arbitrary units in a volume (arbitrary concentration). We originally used ACnc as a “temporary” place-holder for observations with ordinal answers. We then transitioned to replacing ACnc with either “Pr” (for results simply based on whether the analyte is present or not without being determined by a cut off value) or “Threshold” (for observations reported as “positive” or “negative” based on an internal threshold or cut off). As we updated existing terms with the new model, in many cases it was difficult to definitively know how results were determined. Therefore, as of release 2.56, we are using a single property of “PrThr” to represent results based on either the presence or absence of an analyte regardless of whether or not it is based on an internal cut off. This change was approved by the Laboratory LOINC Committee in June 2016.The display name will continue to say “Presence”. All of the existing terms with a Property of “ACnc”, “Pr” or “Threshold” and a Scale of “Ord” were updated to have the Property “PrThr” for the 2.56 release. A single term with Property “ACnt” and Scale “Ord” was also updated to have the Property “PrThr.” Examples: Clonazepam:PrThr:Pt:Ser/Plas:Ord Hepatitis B virus surface Ag:PrThr:Pt:Ser/Plas:Ord:Confirm Burkholderia mallei:PrThr:Pt:XXX:Ord:Organism specific culture VKORC1 gene.c.1173C>T:PrThr:Pt:Bld/Tiss:Ord:Molgen The property of “Prid” will continue to be used when the result is selected from a list of organisms, as described above. NOTE: For order sets/panels, the property field may be populated by a dash (-). Correct assignment of properties tends to be the most difficult task for new users of LOINC. Appendix E provides more explanation and many detailed examples. Table 8: Example LOINC properties Enzymatic Activity CAct *Catalytic Activity CCnc Catalytic Concentration CRto Catalytic Ratio CCnt *Catalytic Content CFr *Catalytic Fraction CFr.DF Decimal catalytic fraction CRat Catalytic Rate RelCCnc Relative Catalytic Concentration CSub Catalytic Substance EntCat *Entitic Catalytic Activity EntLen Entitic Length EntLogNum Logarithmic entitic number EntMass Entitic Mass EntNum *Entitic Number EntVol *Entitic Volume EntSub Entitic Substance Entitic 21 LOINC® Users’ Guide - June 2016 Table 8: Example LOINC properties EntSRto Entitic Substance Ratio Mass Mass Mass ArMass Mass/Area MCnc *Mass Concentration MCncSq Mass Concentration Squared MCnt Mass Content MDiff Mass difference MFr *Mass Fraction MFr.DF Mass Decimal Fraction MFrDiff Mass Fraction Difference MRat Mass Rate MRto Mass Ratio RelMCnc *Relative Mass Concentration RelMRat Relative Mass Rate ThrMCnc *Threshold Mass Concentration MCncDiff Difference in Mass Concentration Percent Difference in Mass Concentration MCPctDiff Substance (Moles/Milliequivalents) RelSCnc *Relative Substance Concentration Sub *Substance Amount SCnc *Substance Concentration SCncSq Substance Concentration Squared SRto *Substance Ratio SCnt *Substance Content SFr *Substance Fraction SFr.DF Decimal Substance Fraction SRat *Substance Rate RelSRat Relative Substance Rate ThrSCnc LsCnc Threshold Substance Concentration Difference in Substance Concentration Log substance concentration Num *Number Naric Number Aeric (number per area) NCnc *Number Concentration (count/vol) NCnt Number Content = Count/Mass NFr *Number Fraction NRat Number=Count/Time NRto Number Ratio LnRto Log Number Ratio LnCnc Log Number Concentration SCncDiff Counts Volumes Vol *Volume 22 LOINC® Users’ Guide - June 2016 Table 8: Example LOINC properties VCnt *Volume Content VFr *Volume Fraction VFr.DF Volume Decimal Fraction VRat *Volume Rate VRatCnt Volume Rate Content VRatRto Volume Rate Ratio VRto *Volume Ratio RelVol Relative Volume RelVRat Relative Volume Rate ArVol Volume/Area ArVRat Volume Rate/Area VFrDiff Difference in Volume Fraction VPctDiff Percent Volume Difference VRtoPctDiff Percent Volume Ratio Difference Time ClockTime Clock Time Time Time Duration TimeDif Difference in time duration TimeFr Time Fraction TRto Time Ratio TQ2 Timing Quantity 2 RelTime *Relative Time Date Date DateRange Date Range DtTmRange Date and Time Range TmStp Time Stamp—Date and Time ACnc Arbitrary Concentration ACnt Arbitrary Content ThrACnc Threshold Arbitrary Concentration ARat Arbitrary Rate LaCnc Log Arbitrary Concentration RelACnc Relative Arbitrary Concentration AFr Arbitrary Fraction Arbitrary Other properties Accel Acceleration Addr Address Anat Anatomy Angle Angle Aper Appearance Arb *Arbitrary Area Area ArArea Area/Area AreaFr Area Fraction 23 LOINC® Users’ Guide - June 2016 Table 8: Example LOINC properties AreaRto Area Ratio Bib Bibliographic Citation Circ Circumference CircFr Circumference Fraction Class *Class ColorRto Color Ratio Compli Compliance CompliRto Compliance Ratio Cmplx Complex Desc Description Diam Diameter Dosage Dosage Elpot Electrical Potential (Voltage) ElpotRat Voltage Rate (=Amperage) ElpotRto Electrical Potential Ratio EmailAddr E-mail Address ArEnrg Energy/Area EngCnc Energy Concentration EngCnt Energy Content EngDiff Energy Difference EngFr Energy Fraction EngRat Power = Energy/Time RelEngRat Relative Power EngRatFr Energy Ratio Fraction EngRto Energy Ratio Enrg Energy Equ Equation Fcn Function Find Finding FldConduct Fluid Conductance FldResist Fluid Resistance Force Mechanical Force Freq Frequency Hx History Imp Impression/interpretation of study ID Identifier Instrct Instructions InvLen Inverse Length Inverse VI Inverse Inspired Volume Len Length LenFr Length Fraction LenRto Length Ratio LogLenRto Log Length Ratio ArLen Length/Area Likelihood Likelihood 24 LOINC® Users’ Guide - June 2016 Table 8: Example LOINC properties Loc Location LogInvPct Log Inverse Percent LogRtoElp Log Ratio Electrical Potential MoM Multiple of the median Morph Morphology NumRange Number range OD Optical density Osmol *Osmolality PctDiff Percent difference Pn Person name PrThr Presence or Threshold Prctl Percentile Prid Presence or Identity PPres *Pressure (partial) PPresDiff Difference in Partial Pressure PPresRto Partial Pressure Ratio Pres Pressure PresRat Pressure Rate PressDiff Difference PresRto Pressure Ratio Quintile Quintile Ratio Ratio Range Range RatDiff Rate Difference RelRto Relative Ratio Resis Resistance ArResis Resistance/Area SatFr *Saturation Fraction Score Score ScoreDiff Score difference ScoreRange Score range Seq Nucleotide sequence Shape Shape Susc Susceptibility Temp *Temperature TempDiff Temperature difference Tele Telephone number Tscore T Score TscoreDiff T Score difference Txt Text Threshold *Threshold ThreshNum Threshold Number Titr Dilution Factor (Titer) Type Type URI Uniform Resource Identifier 25 LOINC® Users’ Guide - June 2016 Table 8: Example LOINC properties Vel *Velocity VelRat Velocity Rate VelRto *Velocity Ratio Visc Viscosity Zscore Z Score * = from IUPAC Silver Bookxx 2.4 Time Aspect (Point or moment in time vs. time interval) (3rd part) One can either measure a property at a moment (point) in time or measure it over a time interval and integrate, in the mathematical sense, over time. In the latter case, we aggregate a “series” of physiologic states into a single scalar value that reflects some “average” property measured over the specified time interval. Intervals also have relevance for rate measurements such as excretion (substance rate or mass rate) or clearances (volume rates). The amount over an interval is often expressed as a mass rate (MRat, e.g., g/24h) or a substance rate (SRat, e.g., mol/24h). Interval measurements often apply to urine and stool (e.g., collection over 24 hours and calculation of a concentration, total amount, or clearance). They also apply to clinical measurements such as urine outputs where we have shift totals and 24-hour totals. Event counts on physiologic monitors, such as the number of premature ventricular contractions (PVCs) over 24 hours on a Holter monitor, are also of this type, as are look back periods for survey instruments. The allowed values for non-point time aspect are defined as a syntax exactly like the syntax for the times in challenge tests, e.g., <numeric value><S|M|H|W> The most common one is 24H. Table 9 gives some other examples. For urine collection, 24H is the “standard” integrated measure and these are almost always reported as mass rates (MRat), substance rates (SRat), or catalytic (CRat) rates. These would contrast with spot or random urine tests that are represented as point (PT) measures in our nomenclature and usually reported as concentrations -- MCnc, CCnc, or SCnc for mass, catalytic, and substance concentrations respectively. However, we can also report the average concentration on a 24-hour specimen – in this case the time aspect value would be 24H but the property would be MCnc/SCnc/CCnc instead of MRat/SRat/CRat. The designation of 24H collection is maintained for tests that traditionally have reference ranges based on amount of substance of a component cleared or excreted in 24 hours. However, a given specimen could have a 23-hour collection time and would still be called a 24H study. Depending upon the policies and procedures of the lab, they might extrapolate the reported value to what it would have been if the collection continued for the full 24 hours and report it as moles per day. We also allow indirect specifications of a time window. Stdy identifies the duration of the study (without specifying an exact time); Enctr identifies the Encounter (ER visit, hospital stay, etc.). Sample volumes reported for timed measurements are carried in other fields or as separate “test” results in other OBX segments. 26 LOINC® Users’ Guide - June 2016 Table 9: Example Duration Categories Abbr. Duration Descriptions Stdy To identify measures at a point in time. This is a synonym for “spot” or “random” as applied to urine measurements. Duration of the study Enctr Duration of an encounter (hospital stay, visit). Pt Episode Episode Gt 1H Greater than 1 hour Ge 1 Hr Greater than or equal to 1 hour Lt 1H Less than 1 hour Procedure dur RptPeriod XXX * (star) Abbr. 2.4.1 Duration of the procedure (surgery, etc.) Reporting period Not specified; time will be reported in another part of the electronic message Life of the “unit”. Used for blood products. Description Abbr. Description Abbr. Description 1M 1 minute 7H 7 days 5 minutes 8H 7 hours 8 hours 7D 5M 14D 14 days 10M 10 minutes 9H 9 hours 30D 30 days 15M 15 minutes 10H 10 hours 90D 90 days 20M 20 minutes 12H 12hours 180D 180 days 30M 30 minutes 18H 18 hours 1W 1 week 45M 45 minutes 24H 24 hours 2W 2 weeks 90M 90 minutes 48H 48 hours 3W 3 weeks 1H 1 hour 72H 4 weeks 2 hours 1D 72 hours 1 day 4W 2H 1MO 1 month 2.5H 2.5 hours 2D 2 days 2MO 2 months 3H 3 hours 3D 3 days 3MO 3 months 4H 4 hours 4D 4 days 6MO 6 months 1Y 1 year Lifetime Lifetime 5H 5 hours 5D 5 days 6H 6 hours 6D 6 days Time Aspect Modifier The second and optional subpart of the time component allows an indication of some sub-selection or integration of the measures taken over the defined period of time: 8H^max heart rate would be the highest heart rate observed over 8H (Shift). Min, max, first, last, mean are the other possible values for this subpart. When nothing is stored in this subpart, we assume a mean value over the time period in questions. Valid values for this subpart are listed in table below. Table 10: Time Aspect Modifier Codes Time Description min Minimum value over interval max Maximum value over interval frst First value observed during an interval last mean Last value observed during an interval Mean of all of the values observed on the interval (This is the default selection.) 27 LOINC® Users’ Guide - June 2016 2.5 System (Sample) Type (4th part) System (sample) type is the fourth part of the fully specified test name. It consists of two subparts; the first part names the system, the optional second part, delimited with a “^”, indicates the super system source of the sample if it is not the patient, e.g., fetus, blood product unit, donor, etc. We define different tests for the combination of component (analyte) and type of system (sample) that are commonly reported. In practice, laboratories include a relatively small range of sample types in their test names. Chemical tests commonly distinguish between serum, urine, blood, and cerebrospinal fluid. Microbiology cultures tend to distinguish between greater numbers of sources. The first part of the system field should be coded using the abbreviations listed in Table 11. Since this list was defined for reporting sample type in a field of the HL7/ASTM message that is quite independent of the test/measure name, we do not imply that all such types will find their way into distinct LOINC names. However, when a distinction by type of system is required in the name, it should be represented by one of these codes. For many chemistry tests we have included in the LOINC database a test name for identifying miscellaneous types of body fluid (Body fld), to provide a way to distinguish tests that are performed on fluid types that are not explicitly represented in the database. We use “XXX” in the system to identify a material that is unknown or not specified — it could be solid or fluid, for example. XXX is also used in the system when the material is specified, but recorded elsewhere in the HL7/ASTM message. Yet, using XXX as a system can be problematic (see also “Special issues related to XXX as a system” below). When should we lump a variety of specimen types under the nonspecific “Body fld” and when we should give a body material its own unique name for a given component? The decision depends upon the degree to which laboratories have reported the system-component pair as a separate “result” and the degree to which the normal ranges for a given component-system have been standardized. By this rule, we will always define different tests for serum and for urine, when a component can be measured in both. We define sweat sodium as a distinct test because it is a standardized test used to diagnose cystic fibrosis. We did not define duodenal fluid sodium as a separate LOINC code because this measure has not been standardized. This does not mean that the specifics about the system would be ignored. It just means that this information would be recorded in another field of the message (the specimen field of the HL7 OBR segment), not in the name. Generally, we will specify the type of system to distinguish at least among blood, urine, cerebrospinal fluid, pleural fluid, synovial fluid, and peritoneal fluid. For many types of tests, the distinction between plasma and serum is irrelevant. When testing on serum or plasma is clinically equivalent, the system should be recorded as Ser/Plas, meaning “either Serum or Plasma”. Sometimes the test can only be run on either plasma or serum; the component will then be associated with either Ser or Plas in one observation. If the test can be run on either but the results are different and standardized (a very rare circumstance), two separate tests will be defined in our file, one with a system Plas and one with a system Ser. The current LOINC database includes some Ser tests and some Plas tests that should really be Ser/Plas. As we determine that a Ser or Plas test really should have been designated Ser/Plas, we will change the designation. As with Ser and Plas, when testing on various specimens is clinically equivalent and the system for the existing test(s) includes only one or a few of those systems, we will review such tests upon request and update them as appropriate to include the additional system(s). 28 LOINC® Users’ Guide - June 2016 If the test is run on a combination of specimens (such as a ratio of substance found in CSF and plasma) the sample types are joined with a “+”, for example, Plas+CSF, Ser+CSF, or Isolate+Ser.. Details about the exact source and collection method (e.g., blood drawn from the right arm and maintained on ice) are not a proper part of the test name and are reported in other parts of the message. For example, the SPM specimen segment of an HL7 message can be used to convey detailed information regarding the type of specimen, where and how it was collected, who collected it, and some basic characteristics of the specimen. Earlier versions of HL7 used OBR-17 as a field to report specimen source. Table 11: Example Laboratory System/Sample Types Abbr. Name Abbr. Name Abbr. Name Abscess Abscess Exhl gas Exhaled gas (=breath) Saliva Saliva Amnio fld Amniotic fluid Fibroblasts Fibroblasts Semen Seminal fluid Anal Anus Fistula Fistula Ser Serum Asp Aspirate Food Food sample Skin Skin Bil fld Bile fluid Gas Gas Sputum Sputum BldA Blood arterial Gast fld Gastric fluid/contents Sptt Sputum - tracheal aspirate BldL Blood bag Genital Genital Stool Stool = Fecal BldC Blood capillary Genital fld Genital fluid Sweat Sweat BldCo Blood – cord Genital loc Genital lochia Synv fld Synovial fluid (Joint fluid) BldMV Blood- Mixed Venous Genital muc Genital mucus Tear Tears BldP Blood – peripheral Hair Hair Thrt Throat BldV Blood venous Inhl gas Inhaled gas Platelets Thrombocyte (platelet) Bld.dot Blood filter paper Isolate Isolate Tiss Tissue, unspecified Body fld Body fluid, unsp WBC Leukocytes Tlgi Tissue large intestine Bone Bone Line Line Tsmi Tissue small intestine Brain Brain Liver Liver Trachea Trachea Bronchial Bronchial Resp.lower Lower respiratory Tube Tube, unspecified Burn Burn Lung tiss Lung tissue Ulc Ulcer Calculus Calculus (=Stone) Bone mar Marrow (bone) Urethra Urethra Cnl Cannula Meconium Meconium Urine Urine CTp Catheter tip Milk Milk Urine sed Urine sediment CSF Cerebral spinal fluid Nail Nail Unk sub Unknown substance Cvm Cervical mucus Nose Nose (nasal passage) Vag Vagina Cvx Cervix Nph Naspopharynx Vitr fld Vitreous Fluid Col Colostrum Penile vessels Penile vessels Vomitus Vomitus Cnjt Conjunctiva Penis Penis Bld Whole blood Crn Cornea Pericard fld Pericardial fluid Water Water Dentin Dentin Periton fld Peritoneal fluid /ascites Wound Dial fld Dialysis fluid Dial fld prt Peritoneal dialysis fluid XXX Dose Dose med or substance Placent Placenta Drain Drain Plas Duod fld Duodenal fluid Plr fld Ear Ear PPP Plasma Pleural fluid (thoracentesis fld) Platelet poor plasma Endomet Endometrium PRP Platelet rich plasma Wound XXX applies when the specimen can be almost any kind of specimen or is unknown. This specimen type should be used sparingly (see discussion below). When a test with this system is used, the specific specimen for a given test should be identified in another part of the message. 29 LOINC® Users’ Guide - June 2016 RBC Erythrocytes Pus Pus Eye Eye RBCCo Red Blood Cells Cord These abbreviations are used in the laboratory LOINC codes. Systems in clinical LOINC terms are spelled out in full and should be easily understood. 2.5.1 Special issues related to XXX as a system Increasingly we get requests, often from the public health context, for tests with XXX as the specimen. XXX is a valid LOINC specimen, and often needed in many cases. However, LOINC typically needs a term with a more specific specimen instead of, or in addition to the XXX. Recall that XXX can be used to represent any kind of specimen (insects, road kill, and ingested food) when the material is unknown or specified elsewhere in the HL7/ASTM message. LOINC already has some general specimen terms that are broad but more constrained than XXX. For example, we have Bld/tiss and Body fld, which represents fluid from all of the serosal cavities, (though this also deserves discussion). We can create more such general specimen terms if needed. Use of XXX for the specimen can create problems. Firstly, the reference ranges for measures on a continuous scale change with specimen differences, and most systems depend upon the test code to get to the reference ranges. So using the same code for very different specimens can break the range checking in many systems. Of course the XXX specimen type is most commonly requested for microbiology tests used to identify micro-organisms by culture, DNA/RNA or specific antigens. In this case the nature of the specimen might not change the clinical implication for some organisms; we suspect that anthrax found anywhere in the body has the same implication. But it does make a big difference for some organisms that are natural inhabitants of the skin or digestive system, but not of the blood. Thirdly, if there is no hint of the specimen in the test name, clinicians will have a more difficult time ordering common microbiology tests. They won’t be able to order urine culture and blood culture each with a single click, and laboratories will have a more difficult time managing these orders. This is especially true given the current state of many HL7 messages that only rarely use codes in the specimen field. (Granted, there is hope for the future). Fourthly, and most importantly, there is the issue of approved use. Package inserts are very specific and limiting about the specimens for which the test kit is approved. We have had a recent request for a test with specimen of XXX whose package insert allowed its use only on Saliva. What do we do? Referral laboratories tend to define tests for class of specimens approved for use on the instruments/test kits they employ. We have received requests for terms with XXX but the test is really only used for specimens from body parts that can “catch” STD. So, the bottom line is that we won’t accept requests for tests with XXX specimens without a narrative description of the most common specimen and some sense of the range of specimens for which it is used. We will likely argue for either adding a distinct code for the dominantly common specimen (e.g. Stool for ameba histolytica) or the specimen prescribed by the package insert, or for entertaining a new specimen code broader than those now available but narrower than XXX to accommodate a particular need, e.g. sterile body fluid, or Genital/anal/throat (for STD specimens). This will, of course, take time and discussion. 30 LOINC® Users’ Guide - June 2016 2.5.2 Super system (2nd subpart) The second subpart of the system identifies a “super-system” when it is not the patient, e.g., a blood product unit (BPU), a bone marrow donor, or a fetus. When the super system is not included in a name, “patient” is the assumed default value. Note: we use the term “fetus” broadly to include embryo, placenta and products of conception. For instance, an example of representing a coagulation study that uses measures on both patient and a control might be: Coagulation reptilase induced:Time:Pt:PPP:Qn:Coag Coagulation reptilase induced:Time:Pt:PPP^control:Qn:Coag Blood banks often report red blood cell antigens for the patient and for each blood product pack assigned to that patient. So we have: A Ag:PrThr:Pt:RBC:Ord A Ag:PrThr:Pt:RBC^BPU:Ord Note: The inclusion of the super system as part of the system represents a change from versions of LOINC prior to Release 1.0K, May 1998. Earlier versions included this information in the (no longer valued) fourth subpart of the component. 2.6 Type of Scale (5th part) The fifth data part of the test name specifies the scale of the measure, and is a required part. The abbreviation of the type of scale (previously called precision), given in Table 12, should be used in the fully specified name. Note that with the release of Version 1.0K, May 1998, we changed the codes for these from SQ to ORD and from QL to NOM to more accurately identify the meaning. Table 12: Type of Scale Scale Type Abbr. Description Quantitative Qn Ordinal Ord Quantitative or Ordinal OrdQn Nominal Nom Narrative Nar “Multi” Multi Document Doc The result of the test is a numeric value that relates to a continuous numeric scale. Reported either as an integer, a ratio, a real number, or a range. The test result value may optionally contain a relational operator from the set {<=, <, >, >=}. Valid values for a quantitative test are of the form “7”, “-7”, “7.4”, “-7.4”, “7.8912”, “0.125”, “<10”, “<10.15”, “>12000”, 1-10, 1:256 Ordered categorical responses, e.g., 1+, 2+, 3+; positive, negative; reactive, indeterminate, nonreactive. (Previously named SQ) Test can be reported as either Ord or Qn, e.g., an antimicrobial susceptibility that can be reported as resistant, intermediate, susceptible or as the mm diameter of the inhibition zone. (Previously named SQN) We discourage the use of OrdQn in other circumstances. Nominal or categorical responses that do not have a natural ordering. (e.g., names of bacteria, reported as answers, categories of appearance that do not have a natural ordering, such as, yellow, clear, bloody. (Previously named QL) Text narrative, such as the description of a microscopic part of a surgical papule test. Many separate results structured as one text “glob”, and reported as one observation, with or without imbedded display formatting. A document that could be in many formats (XML, narrative, etc.) Set Set Used for clinical attachments 31 LOINC® Users’ Guide - June 2016 Quantitative (Qn) identifies scales that can be tied to some physical quantity through a linear equation. This means that if we have two reports for the same quantity one with a value of 5 and the other a value of 10 we know that the two are related in amount through the linear equation Y = aX +b. When the intercept, b, is non-zero, we have a difference scale. (Fahrenheit temperature is a difference scale.) When it is zero we have a ratio scale (Kelvin temperature is a ratio scale).22,23A Qn value may be reported as a value for a “continuous” scale, as is the case for serum sodium, or it may be reported from a series of discrete values, as is the case for titers, e.g., 1:16, 1:32. Ordinal (Ord): Some observations have values that are well ordered, e.g., “present, absent”, “1+, 2+, 3+”, or “negative, intermediate, positive”, but the values have no linear relationship to one another. We do not know that positive is two or three times as much as intermediate, we just know that positive is more than intermediate. These kinds of observations have an ordinal scale (Ord). Tests with “yes/no” answers are always ordinal (Ord). Tests reported as negative when less than the detection level but as quantified values otherwise should be regarded as quantitative (Qn). Quantitative/Ordinal (OrdQn): Rarely, a result can be reported in either an ordinal or quantitative scale. The principal example of this scale is a MIC, which can be reported as either resistant/intermediate/susceptible or by the MIC numeric value. The need for terms with OrdQn as scale was further obviated by clarification from HL7 that results such as "POS" and "NEG" should go in the OBX-8 field for normalcy status. Thus, LOINC codes with scale of Qn can be appropriately used in these cases even if the "values" coming back are coded interpretations of the true numeric result value. Nominal (Nom): Some observations take on values that have no relative order. Think of the numbers on football jerseys. These simply identify the players; they do not provide quantitative information or rank ordering of the players. We refer to these as nominal (Nom) in scale. Blood culture results provide a good example. Possible values could be Escherichia coli (or a code for E. coli) or Staphylococcus aureus. Other examples are admission diagnoses and discharge diagnoses. Any test or measure that looks broadly at patient or specimen and reports the name of what it finds is a Nom scale. The values of nominal scaled observations are assumed to be taken from a predefined list of codes or from a restricted vocabulary (e.g. a menu of choices). These observations would typically be sent in an HL7 message OBX segment with a Coded Element (CE) data type (in earlier HL7 versions) or its superseding Coded with No Exceptions (CNE) and Coded With Exceptions (CWE) variants (later HL7 versions). It is important to note that the CE and CWE data types allow values to be set as codes with their print text or just as their print text alone. These data types and the Nom scale would not be used for running narrative. Narrative (Nar): Some observations are reported as free text narrative. The content is not drawn from a formal vocabulary or code system. A dictated present illness would be an example of a scale of narrative (Nar). Many clinical LOINC codes will come in two versions: one for the nominal (coded) version and one for a narrative (free text) version. We strongly encourage all reporting to be at the most granular level of detail. That is, if three numbers were reported, they would each be reported under a unique LOINC code and transmitted in a separate HL7 OBX segment. Occasionally reporting systems are not able to comply with this dictum. For example some chromatography instruments can identify chemicals from the entire spectrum of known chemicals (CAS identifies more than 10 million distinct chemicals) and we may not have specific LOINC codes for reporting out these details. We have designated the scale of Multi to identify results that include many 22 Stevens SS. Measurement, statistics, and the chemapiric view. Like the faces of Janus, science looks two ways – toward schematics and empirics. Science 1968;161:849-856. 23 Tang YW, Procop GW, Persing DH. Molecular diagnostics of infectious diseases. Clin Chem 1997;11:2021-2038. 32 LOINC® Users’ Guide - June 2016 separately structured results as one text “glob” with or without imbedded (display formatting). Some laboratories report all of the details of many multiple measure tests under such globs with test names that correspond to their order name. We strongly discourage such reporting. It defeats the very purpose of individual codes to tag content. Note: Because the individual components of an Order set/Panel often have different scales, the scale for the order set term may be populated by a dash (-). 2.7 Type of Method (6th part) The method by which the test was performed is the sixth part of the test name. Methods need only be expressed as part of the name when they provide a distinction between tests that measure the same component (analyte) but which have different clinical significance or have a different clinical reference ranges. For instance, whole blood glucose tested with a test strip might be distinguished in the method field. The list of methods given in Table 13 is not exhaustive; we have included only those methods that are abbreviated in the database or which otherwise require explanation or clarification. Most methods are fully spelled out in the database and should be self-explanatory. Laboratories do not include the method as part of the name for most common chemical and hematological tests. They often need the freedom to choose the instrument according to time of day, urgency of the request for service, availability of the instruments and so on, even though the instruments may employ different methods. The laboratories then adjust each of the “interchangeable” instruments to produce equivalent results even though the instruments may use different methods. Therefore, we do not want to distinguish too finely on the basis of methods. When a LOINC term does include a method, it usually describes a type or class of method and does not make fine-grained distinctions except in special cases. Though method is rarely significant for many chemical and hematological tests, it is often important to immunochemical/serology testing, because the sensitivity and specificity of some tests varies greatly with the method. For this reason, you will commonly see methods included in microbiology tests and coagulation tests within the LOINC database. This does not mean that detailed information about the method is irrelevant, but that it is not always useful or practical to bind it to the test name. It is an essential element of the internal quality assurance of laboratories and there are fields for reporting other details about the method in HL7 and CEN TC251 test result messages. Table 13: Laboratory Method Type Abbreviations Method Abbr. Agglutination Aggl Coagulation Assay Coag Complement-dependent Cytotoxicity Complement Fixation Comp fix Cytology Stain Cyto stain DNA Nucleic Acid Probe Chromogenic/Enzymatic Assay Comment To distinguish coagulation assays based on clotting methods that test function/activity from Immune methods that detect the presence of clotting factors and may or may not be functional assays. CDC Probe Chromo The staining method used for pap smears, fine needle aspirates and other cell stains. See section 2.7.1 for more information about probes. To distinguish coagulation assays based on chromogenic (enzymatic) 33 LOINC® Users’ Guide - June 2016 activity. Immunoassay IA Flocculation Assay Floc Hemagglutination Inhibition HAI Hemagglutination HA Immune Blot IB Immune Fluorescence IF Latex Agglutination LA Encompasses all immunoassays with a few exceptions, including Immune Blot and Immune Fluorescence, which were created based on historic usage. Encompasses direct and indirect Encompasses DFA, IFA, FA. Usually applies to cells and smears examined microscopically so that both the “where” and the “what” can be assessed, but can also be used on fluids in a way similar to ELISA. Leukocyte Histamine Release LHR Minimum Inhibitory Concentration MIC Antibiotic susceptibilities Minimum Lethal Concentration MLC Also called MBC (minimum bactericidal concentration) General class of methods used to detect genetic attributes on a molecular basis including RFL, PCR and other methods. Molecular Genetics Molgen Neutralization Neut Radioimmunoassay RIA Rapid Plasma Reagin RPR Serum Bacterial Titer SBT Rapid Plasma Reagin RPR Vertical Auto Profile VAP Visual Count Venereal Disease Research Laboratory VC 2.7.1 VDRL Microscopic flocculation test, using cardiolipin-lecithin-cholesterol antigen with carbon particles. Determines the serum dilution that is capable of killing microorganisms. Microscopic flocculation test, using cardiolipin-lecithin-cholesterol antigen with carbon particles. Developed by Atherotech, Inc. Microscopic flocculation test DNA/RNA probes/measures We distinguish three kinds of DNA probe methods: 1. Probe without amplification (Probe) 2. Probe with target amplification (Probe.amp.tar) a. See Table 14a for a list of methods that would be identified as Probe.amp.tar in the method part of the LOINC term. 3. Probe with signal amplification (Probe.amp.sig) a. See Table 14b for a list of methods that would be identified as Probe.amp.sig in the method part of the LOINC term. Table 14a: Examples of specific methods that would be classed as target amplified DNA/RNA Probe.amp.tar (includes nucleic acid target amplification and probe) PCR* Polymerase Chain Reaction TMA* Transcription Mediated Amplification NASBA* Nucleic Acid Sequence Based Analysis Applies to DNA, RNA Roche Molecular Systems (thermal cycler) Requires repeated cycles of heating and cooling-each cycle doubles the target Applies to DNA, RNA Gen-Probe, Inc. (isothermal) Applies to RNA, DNA Organon-Tenika Corp (isothermal) 34 LOINC® Users’ Guide - June 2016 SDA* Strand Displacement Amplification LAT* Ligation-Activated Transcription 3SR SR* 3 Self-Sustaining Sequence Replication LCR* Ligase Chain Reaction QBR* Q-Beta Replicase or probe amplification category method Applies to DNA Becton Dickinson (isothermal) Applies to RNA, DNA Bartel's Diagnostic (isothermal) Also probe amplification category method Abbott Laboratories (thermal cycler) Applies to DNA RNA Gene Track Systems. (isothermal) Table 14b: Examples of specific methods that would be defined in LOINC as signal amplification methods Probe.amp.sig (includes nucleic acid signal amplification and probe) HPA* Hybridization Protection Assay bDNA* Branched Chain DNA --------- Applies to RNA Gen-Probe Accuprobe Applies to DNA, RNA Chiron Corp (isothermal) Hybrid Capture *The items in the first column of the above table are not meant to be used as methods in LOINC terms. 2.7.2 PCR assays with non-probe analyte detection methods In LOINC version 2.54, we added a new method for target amplification with melt curve analysis (Melt.amp.tar) to distinguish assays that use melt curves rather than probes for analyte detection. For version 2.56, we created a more encompassing non-probe based method (Non-probe.amp.tar) that is used for any PCR assay with non-probe based detection technology, including melt curve analysis, and which still distinguishes from probe-based assays (Probe.amp.tar). The existing terms with the Melt.amp.tar method were updated to use the Non-probe.amp.tar method for the 2.56 release. 2.7.3 Immune Assays Immune assays in the LOINC world include a large swath of tests. We have historically lumped together immune assays that detect the linking of antigens and antibodies via special signaling mechanisms, such as EIA, ELISA, chemiluminescence and other similar tests that produce one measure (quantitative or qualitative) of the analyte of interest. We thought of this class of tests as “EIA-like” and in the absence of an existing short acronym to describe their constituents, we borrowed “EIA” to provide this meaning in the Short Name and used Immunoassay in the Long Common Name to signal that this method type was not limited to pure EIA tests. In LOINC version 2.56, we changed the name of the EIA method to IA (and EIA.rapid to IA.rapid), in order to mitigate some of the confusion regarding the EIA name. The Long Common Name will continue to use Immunoassay as it always has, and the Short Name will use IA rather than EIA. Some immunologic tests have always had their own method type and were never lumped in the category of EIA-Immune assays described above. Immune blot (IB) tests, immune diffusion and immune based flow cytometry (FC) tests have always had specific method names. They are different because they usually yield multiple related observations. Immune fluorescence tests (IFA, DFA and ACIF) also have had their own method type, namely IF, because they can provide information about the presence or amount of a target analyte and its location on a smear, tissue slice or cell (though all IF tests do not provide such location information). LOINC has also assigned distinct method types to some other immunologic tests including VDRL, Latex fixation and other kinds of agglutination tests because these were their historic names or they had specialized uses or limits. We classify peroxidase and all other non-IF immune stains of tissue under the method category immune 35 LOINC® Users’ Guide - June 2016 stain. 2.7.4 Coagulation We distinguish among three kinds of coagulation methods: coagulation (Coag), which measures the coagulation activity, immune (Imm), which measures the amount of the coagulant protein, not its activity, and chromogenic (Chromo), which measures the coagulation factor via enzyme rate (also called enzymatic). 2.7.5 Stains We provide very detailed distinctions among various tissue stains, naming them in full. Stain methods that are modifications of a basic method are named using a <basic>.<modification> syntax, e.g., Methenamine silver stain.Jones 2.7.6 Substrates used to measure enzyme activity For tests that are measuring enzyme activity using various substrates, the name of the enzyme or enzyme group will be the Component and the substrate will be the Method: Mitochondrial respiratory chain enzymes: CCnt: Pt: Fibroblasts: Qn: 1-14C-glutamate substrate 2.7.7 Clinical measures We distinguish reported from estimated and measured value. For example, reported body weight is the stated weight from a patient or surrogate. Estimated body weight is estimated by an observer, and measured would be the body weight as measured on a scale. 2.7.7.1 Oximetry Use of “oximetry” as a Method can cause confusion. For details see the Oxygen Saturation Technical Brief at the end of this guide, but briefly, oximetry has several specific types, including pulse oximetry, co-oximetry and heme-oximetry. Unfortunately, at one time the word “oximetry” was used interchangeably with “pulse oximetry,” which created confusion in LOINC because we have one method called oximetry and another called pulse oximetry. To avoid ambiguity, as of version 2.54 we deprecated most of the terms with oximetry as the Method, and moving forward we will continue to review the ones that are remaining and create new terms with the Method pulse oximetry as needed. 2.7.8 Imaging studies We distinguish among the major imaging modalities for most measures derived from such imaging studies (e.g., cardiac outputs from a MUGA scan, angiography, 2D Echo, Doppler, etc.). 2.7.8.1 Methods that include imaging modality and calculation In some cases, the Method includes two concepts: the imaging modality and the method of calculation for the specific measure. Through LOINC version 2.50 we used the pattern <imaging 36 LOINC® Users’ Guide - June 2016 modality>.<calculation>, for example, US.2D.Teichholz. This format, however, does not clearly differentiate between the two distinct concepts being represented. This is further complicated by our convention of using a dot (.) to specify the submodality (e.g. 2D). Beginning in LOINC version 2.52, we plan to separate the two concepts with a plus (+) rather than a dot (.), so that US.2D.Teichholz becomes US.2D+Calculated by Teichholz method. We will apply this format to new terms moving forward and plan to update existing terms over time. 2.8 Use of curly braces {} in LOINC names In Section 2.5 we described the use of XXX in the System when the material is unknown or specified elsewhere in the HL7/ASTM message. In some domains, particularly clinical observations, we have adopted a newer style of notation with curly braces to indicate that the information is provided elsewhere. For example, LOINC term 32491-3 represents a deep tendon reflex observation where the anatomic location is not specified in the term name: Deep tendon reflex:Find:Pt:{Reflex location}:Ord:Observed Such terms could be used in post-coordinated expressions where the value of “reflex location” is communicated elsewhere. The curly braces notation has the advantage over using XXX in some cases because it allows a more precise indication of the set of possible entities to expect for that piece of information. In the reflex example above, saying {reflex location} narrows the expected set of possible values down to those anatomic regions where a muscle tendon reflex can be observed. We have made use of this notation primarily in the System and Method part of the name. 2.9 Short Convenient Names As of the August 2002 release of LOINC we have included a new field in the LOINC database called “SHORTNAME”. This field will carry a short, mixed case name for the LOINC concept. We have populated these fields for all laboratory and radiology tests. Our goal was to produce names no longer than 30 characters in order to fit within the space allocated by most laboratory reporting systems. In contrast to the formal LOINC name, case is significant in the LOINC short name. When possible, we have used common acronyms and common names rather than the more formal name rules of the full LOINC name. For example, we used the English names of allergens in the short names rather than the formal Latin species names (in part because they were shorter). The LOINC short names are subject to change and should not be used as identifying keys in any database. These names have been created via a table driven algorithmic process. We have used all upper case to represent acronyms, and mixed case in organism names as specified in naming conventions (e.g., genus is capitalized, species is not). For virus names we used the acronym assigned by Index Virum where available. 2.10 Long Common Names LOINC has received periodic requests from users to produce “pretty” display names that could be used in user interfaces, etc. While systematically created names (like the standard LOINC short names) can be 37 LOINC® Users’ Guide - June 2016 guaranteed to be unique, they are sometimes not the most user-friendly. We have always expected that users would link their own local preferred names to LOINC terms for use in reports and displays. In contrast to systematically-created names, user-friendly names are often ambiguous. After collecting and reviewing display names from several sources, we decided to create a new algorithmically-generated Long Common Name based on patterns we observed. As of the January 2009 release, we have included a new field in the LOINC Table called “LONG_COMMON_NAME”. These names have been created by an algorithmic process and are checked for uniqueness. Most abbreviations and acronyms that are used in the LOINC database have been fully spelled out in English. For allergens, the common English names are used instead of the more formal Latin species names. For coagulation, the more commonly used phrases such as “Prothrombin time” have been used. We started creating long common names first for laboratory terms, but are now producing them for all terms. The text strings for the long common names are subject to change over time as we continue to refine the algorithmic process and collect feedback from users. In particular, many of the long common names for clinical terms have not had as intense focus as the laboratory terms have, so we expect these to be refined over time. In LOINC release 2.54, many of the echocardiography and ophthalmology were updated based on input from DICOM and the National Eye Institute, respectively. 2.11 Classes We assign each LOINC term to a general category called a Class. These categories are relatively broad and are intended to make it easier to sort and browse the database. They are not intended to be binding definitional characteristics of the term, and we may refine them over time. A more detailed listing of the Classes is presented in Appendix B. Throughout this document many of the naming conventions and approaches are described in reference to a Class of terms. Here we provide a bit of explanation about some of the laboratory term classes. The class of Microbiology includes all tests used to identify microorganisms and evidence for infection by specific organisms as well as cultures direct microscopic exams that identify organisms or prove evidence for present or past infection with specific organisms. Microbiology includes tests for antibodies, antigens, DNA and RNA. The Serology class does not include measures antibodies or antigens related to microorganisms. Molecular pathology class does not include RNA or DNA based tests for infectious organisms. (They are all included in Microbiology.) The class Blood bank includes all blood bank testing including ABO-Rh testing. Allergy class includes testing for antibodies to allergens (cat dander, trees, etc.). Serology includes rheumatological, and autoantibodies, and antigen measures not covered by these two classes. Hematology/cell counts exclude coagulation studies that are found in a separate class. Measures of complement activity are included within Hematology, not Chemistry. Chemistry does not include challenge tests such as Glucose tolerance, ACTH stimulation, etc.; these are in a separate category called Challenge tests. 3 Special Cases 3.1 Findings viewed as variables or as values For some complex tests there are two ways to organize the results into a report. 38 LOINC® Users’ Guide - June 2016 3.1.1 Value Assume a set “X” is made up of five “results” that can have a scale of (absent present) or (0 1). These results could be reported as: Finding 1 = Finding 2 = Finding 3 = Finding 4 = Finding 5 = Present Absent Present Absent Absent - or - or - or - or - or - 1 0 1 0 0 Each finding is then considered a binary variable. This is sometimes called a “panel” approach. 3.1.2 Variable (Multiple Choice) Approach The alternative would be to report this information as a single variable (or multiple-choice question) with many possible values: Variable X - Finding 1, Finding 3 In this case the findings are the values of a variable called Variable X; only the positive findings are reported as values. Many laboratory tests, e.g., those that test for HLA antigens, red blood cell antigens, or screens for toxic substances, could in theory be presented either way. The microscopic part of the differential count and urinalysis could also be described either way. History and physical findings and (given a real stretch) even culture results could be structured in the panel or multiple choice/multiple answer format. A single lab may report red blood cell antigens in either way, as a binary panel or a multiple-choice result, depending upon the purpose of the test. The routine cross and type are reported out in the multiple choice pattern format (only positives from a modest fixed set of tested antigens are reported). But if the tests are being used to prove fatherhood, the results are usually reported as a binary panel. Blood cultures could in theory be regarded as panels: Test Name Escherichia coli Staphylococcus aureus Diphtheroids Streptococcus pneumoniae Pseudomonas aeruginosa Value absent present absent absent present Although in practice such tests are almost always reported in the multiple choice/multiple answer format, as follows: Test Name Blood culture Values P. aeruginosa, S. aureus We bring up these issues to explain why we use a somewhat different data format for some types of tests, and why we sometimes provide for both reporting methods (e.g., HLA blood cell antigen tests) in the LOINC database. When a binary scale is used, the scale will be ordinal (Ord) and the kind of property will usually be presence (PrThr, for results based on the presence/absence of an analyte regardless of whether an internal cut off value is used to determine the ordinal result). When the multiple-choice 39 LOINC® Users’ Guide - June 2016 multiple-answer approach is used, the scale will be nominal (Nom) and the type of property will be presence or identification (Prid). 3.2 Blood bank Red cell antigens will be named in accordance with the American Association of Blood Banking (AABB) naming standards.24 In addition to the antigen or antibody, a modifier would be included in the supersystem (the second subfield of the System field); to indicate whether testing was performed on the patient, donor, or blood product. Unless explicitly stated, testing is assumed to have been on a material collected from a patient. Additional information about the person identified in the fourth subpart, such as the donor's name or relationship to patient, should be placed in other OBX segments, or comment segments of the message, and would not be part of the test name. Blood bank reporting illustrates the need for a method of reporting by panel and by multiple-answer mechanism. The LOINC database provides observation names for both kinds of reporting. 3.2.1 Panel reporting: Each reportable antigen must have its own test, so that each element in a full set of binary tests could be reported as (negative, positive) or (0, 1). The fully specified names of A, AB, B, and O blood types (as observations) would be as follows: Measure of serum antibody against type A blood of donor: A Ab:PrThr:Pt:Ser/Plas^donor:Ord Presence of A antigen on donor's red blood cells: A Ag:PrThr:Pt:RBC^donor:Ord Presence of A antigen on the blood cells in a pack of blood given to the patient: A Ag:PrThr:Pt:RBC^BPU:Ord 3.2.2 Multiple answer reporting: All blood antibodies found (or not found) can also be reported in one result term: Antigens absent:Prid:Pt:BBL^BPU:Nom Antibodies identified:Prid:Pt:Ser/Plas:Nom The LOINC database provides other “observations” for reporting: the status of each blood pack (e.g., held, given, discarded), and for reporting that information when HIS and medical records systems want it; how much of each type of blood product was given at a moment in time; the type of each pack; any adverse reaction to that pack; and the pack number to accommodate laboratories that send this information as discrete observations. Blood product disposition:Type:Pt:^BPU:Nom 24 Walker RH. American Association of Blood Banks Technical Manual. 11th ed. Bethesda, MD: American Association of Blood Banks, 1993. 40 LOINC® Users’ Guide - June 2016 Blood product type:Type:Pt:^BPU:Nom 3.3 Immunocompetence studies (flow cytometry) The CD (Cluster of Differentiation) markers in the LOINC database include all of the single markers and the most commonly reported combinations, e.g., CD11C+CD20C+. Most of these are really measuring the number or percent of cells that bear the specific T-cell marker pattern, in which case they should be specified as a subtype of a lymphocyte, e.g., Cells.CDx. There are other possibilities, and these cell types can also be named; for instance Blasts.CD2 or Abnormal blood cells.CD5. LOINC Components for cells with single markers typically do not include a plus or minus sign after the marker because flow cytometry labs do not report single CD marker-negative results, so when the marker is reported, the plus is implied. In other words, the LOINC Component Cells.CD4 represents the presence of CD4, and we do not have a Cells.CD4- Component, because such a result is not reported. However, when multiple markers per cell are reported, the plusses and minuses are always included, for example, Cells.CD3-CD8-CD57+. Two kinds of measures are of interest. 3.3.1 Number of cells containing the marker The “absolute” number of such cells per cubic millimeter is represented as number concentrations, for example: Cells.CD16C+CD56+:NCnc:Pt:Bld:Qn 3.3.2 Percent of cells containing the marker Percent of cells containing the named marker per 100 cells of that type is represented as number fraction, for example: Cells.CD16C+CD56+/100 cells:NFr:Pt:Bld:Qn 3.4 General approach to microbiology results The inherently complex structure of the results of microbiological cultures presents unique challenges for the goal of standardized observation names. Result Status (Preliminary, Final) should not be reported as a separate observation or as part of the name. It should be reported in the Result Status field (OBR-25) of the HL7 OBR segment. Specimen Type (Serum, Blood, Urine, etc.) will be indicated in the HL7 OBR segment with the Specimen Source field (OBR-15), but may also be represented in the name. Details of specimen collection will usually be noted as OBX segments or comment segments that accompany the culture result message. The observation identifier for the OBX segment will have the fully specified name of “Specimen collection description:Find:Pt:*:Nom” and the Observation Sub-ID field will be used to order or group sets of observations. That is, if the material was collected by swabbing a wound of the right upper arm, multiple OBX segments would be created, each with the name “Specimen collection description:Find:Pt:*:Nom” and the Observation Results fields of the OBX segments would contain respectively “Swab,” “Right,” “Arm,” and “Wound.” (The granularity of the actual terms used in the specimen description is at the discretion of the user. Thus, “Right Arm Wound” as the value of a single OBX segment could be used in place of the three codes described in the previous sentence.) 41 LOINC® Users’ Guide - June 2016 Descriptions of measurement and culture growth will be noted as separate OBX segments that accompany the culture result message. The name of the observation identifier will provide the context of the observation. For instance, the name for a quantitative test of bacteria in a specimen would be: Colony count:Num:Pt:XXX:Qn:VC Descriptions of Gram stain findings will be noted as OBX segments that accompany the culture result message. The name of the observation identifier will be: Microscopic observation:Prid:Pt:XXX:Nom:Gram stain The result values that could be reported with this test (which is a multiple-choice, multiple answer type or observation) might include one or more of the following: Epithelial cells Gram-positive cocci in chains Many Gram-negative diplococci The organisms identified in a culture will be sent as result values in OBX segments. LOINC provides codes to identify the observation, but not for identifying the names of organisms that would appear as result values (i.e. in OBX-5). SNOMED CT is an appropriate source for these organism concepts. While “Throat Culture” is the source of the culture inoculum, it is also a label that indicates what kind of media was inoculated and the other techniques used in the laboratory. So, it is a short hand for a kind of method and such will be recorded as the method part of the name. Thus, “Throat Culture”, “Blood Culture”, and “Clostridium difficile Culture” all represent labels for how a culture was performed. The LOINC naming model for routine cultures is: Bacteria identified:Prid:Pt:<specimen>:Nom:Culture Examples names include: Bacteria identified:Prid:Pt:Bld:Nom:Culture Bacteria identified:Prid:Pt:Brn:Nom:Culture Bacteria identified:Prid:Pt:Stool:Nom:Culture The LOINC names for cultures are based on the expected observations they generate, e.g. “bacteria identified” or “virus identified”. For most routine cultures the users are looking for bacteria. However, in some cases a routine culture may also grow out some fungi like yeasts. Such observations can also be reported under the same test code. But, since the culture would not be optimized for growing out fungi we have a bacteria-focused name. It is worth emphasizing these culture terms are intended for use as both as orders and observations despite having a more result-oriented name. Furthermore, as a matter of good clinical practice, most laboratories perform susceptibility testing on any significant isolate on a reflex basis. So there is no need for codes that say “culture and sensitivity” because it is implied. Thus, an order for 17928-3 “Bacteria identified in Blood by Aerobe culture” would likely trigger several workflow steps, including bottle blood culture, bacteria isolation, identification, and antimicrobial susceptibility testing (which would be reported with appropriate susceptibility terms as described in Section 3.5). 42 LOINC® Users’ Guide - June 2016 LOINC names for methods of staining a sample/material directly (where many descriptive observations are possible) include: Microscopic observation:Prid:Pt:XXX:Nom:Gram stain Microscopic observation:Prid:Pt:XXX:Nom:Dry mount Microscopic observation:Prid:Pt:XXX:Nom:India ink preparation Microscopic observation:Prid:Pt:XXX:Nom:Trichrome stain Microscopic observation:Prid:Pt:XXX:Nom:Giemsa stain Names for results of staining procedures performed on organisms that are growing in culture will use Isolate as the system/sample type. For example: Fungus identified:Prid:Pt:Isolate:Nom:Fungal subtyping Names for organism-specific cultures: Brucella sp identified:Prid:Pt:Bld:Nom:Organism specific culture Bordetella pertussis:PrThr:Pt:Thrt:Ord:Organism specific culture Chlamydia sp identified:Prid:Pt:Gen:Nom:Organism specific culture Legionella sp identified:Prid:Pt:Sputum:Nom:Organism specific culture Note if a test applies to a specific species of organism, the component should include the genus AND species (at least). If the measure applies to a series of species in the same family the string “sp” must be included. If it applies to as subgroup of the genus, then that subgroup should be named. Names for method for general class of organism: Fungus identified:Prid:Pt:Wound:Nom:Culture Bacteria identified:Prid:Pt:CSF:Nom:Culture Again, the Result Value of these tests would be either organism names or other statements of culture outcome. The table below contains valid values of the culture result from the HL7 OBX segment: Table 15: Example Culture Results No growth Gram-positive cocci Small Gram negative rod Escherichia coli Normal flora Candida albicans Presence or Identity (Prid) as a property should be used when the value of a test can identify one set of alternative infectious agents. If the culture is for herpes virus and the culture can have results of herpes virus 1, herpes virus 2, etc., then Prid is the right property. If the culture is for herpes virus and the answer is positive/negative or yes/no, then the property should be presence (PrThr) and the scale ordinal (Ord). 43 LOINC® Users’ Guide - June 2016 3.5 Antimicrobial susceptibilities The drug susceptibility tests are grouped together in the LOINC database under the class ABXBACT. Antimicrobial susceptibility tests are named according to the generic name of the drug tested and the methodology used in testing, with property of susceptibility (Susc), and with scale of quantitative (Qn), ordinal (Ord), or OrdQn. Thus, appropriate names would be: Ampicillin:Susc:Pt:Isolate:OrdQn:MIC Ampicillin:Susc:Pt:Isolate:OrdQn:Agar diffusion Ticarcillin+Clavulanate:Susc:Pt:Isolate:Qn:MLC Table 16 lists methods in drug-susceptibility tests. Table 16: Drug Susceptibility Methods Method Description Agar diffusion Bacterial sensitivity via agar diffusion (Kirby-Bauer) MIC Minimum inhibitory concentration MLC Minimum lethal concentration SBT Serum bactericidal titer Gradient strip Susceptible by E-Test or gradient strip method Methodless codes also exist for each antimicrobial agent. 3.6 Cell counts Quantitative counts of various entities and cells in blood, urine, CSF, and other body fluids may be performed and reported in one of three ways. Cell counts in blood are often reported as absolute counts per unit volume (property number concentration, NCnc), or percent of a general cell type, e.g., percent eosinophils, (property number fraction, NFr). Blood cells are usually reported in such a manner, via either a manual or automated count method. Counts on urine and other body fluids can also be done as direct counts and reported as NCnc or NFr. However, they are more often reported as the number of entities or cells per microscopic high power or low power field, e.g., 5-10 cells per high power field. These are really numbers per area (property Naric). For example, the number of erythrocytes casts per low power field would be reported as: Erythrocyte casts:Naric:Pt:Urine sed:Qn:Microscopy.light.LPF Note that even though the values are reported as a range, the scale is still quantitative (Qn), because the values can be related through a ratio. We use HPF or LPF to identify high power and low power fields respectively. Large entities (such as casts) are usually reported per low power fields, smaller entities per high power fields. One other way such entities are reported is as a pure ordinal, e.g., none, few, moderate, loaded. These would be specified as arbitrary concentration (ACnc) properties with ordinal scale, for example: Erythrocytes:ACnc:Pt:Semen:Ord:Microscopy.light 44 LOINC® Users’ Guide - June 2016 3.7 Skin tests These follow the pattern of a challenge test. For a TB skin test it would be: Tuberculosis reaction wheal^3D post 25 TU ID:Diam:Pt:Skin:Qn Where TU means tuberculin units, ID means intradermal, Diam indicates a measure of the diameter of the wheal and so on. 3.8 Toxicology – Drug of Abuse Screening and Confirmation Many kinds of test methods are used in toxicology: Screening tests include HPLC, EIA, TLC, RIA, GC, and GCMS (rarely). Confirmation tests are GCMS, LCMS, GC, and HPLC. Table 17: Drug of Abuse Methods Abbr. Description HPLC high pressure liquid chromatography TLC thin layer chromatography GC gas chromatography EIA enzyme immunoassay RIA Radioimmunoassay GCMS gas chromatography/mass spectrometry LCMS liquid chromatography/mass spectrometry Many laboratories use GCMS to signal that the test is a confirmation of a previous screening test, but other methods are also used to confirm, and a given method can be used to screen or to confirm a test. However, it is important that two different methods be used for screen and for confirm and that they both be applied with techniques appropriate to the mode (screen or confirm). So the LOINC committee has determined it is better to distinguish the screening from the confirming procedure by the use of the words “screen” or “confirm,” in the method part of the name, rather than by naming a specific method. Hence LOINC will distinguish toxicology method by Screen and Confirm but not by particular methods. Toxicology tests can also be performed on a group of drugs/substances or on individual drugs/ metabolites/ substances. We will develop LOINC names and codes for both categories: groups of analytes, e.g., “barbiturates” and individual analytes, e.g., “phenobarbital.” Group test results are usually reported as ordinal (present /absent) but can also be reported as mass concentrations when the numerator is the total mass of the detectable substances in the group. Group tests at the screening level may also be followed by a confirmation at the group level or by confirms of the individual drug/substance tests at the confirmatory level. Individual drugs/substances may be reported as present/absent (Ord) or as mass (or substance) concentrations (Qn). When individual drugs/substances are reported ordinally, the reporting threshold (the threshold at which a test level is considered positive) may also be reported as a separate “result.” Thus we have separate LOINC codes to report the cutoff used for defining a positive or negative value. 45 LOINC® Users’ Guide - June 2016 3.8.1 Toxicology drug groups General principles: for each “group” of drugs (amphetamines, benzodiazepines, opiates, etc.) we will define the following kinds of LOINC observations: 3.8.1.1 Screen for a group of drugs/ toxic substances “X”:PrThr:Pt:Ord:SYS:Screen for the group as a whole (Answer = present/absent) For example, Amphetamines:PrThr:Pt:Urine:Ord:Screen Example answer: “present” Identify the set of drugs/substances screened for by the group test. The answer will be a list of discrete drug/substance names or codes. “X” tested for:Prid:Pt:SYS:Nom:Screen (Answers = individual drugs that this screening test could detect, from a fixed list) For example, Amphetamines tested for:Prid:Pt:Urine:Nom:Screen (nominal) Example answer = “amphetamine, methamphetamine, dextroamphetamine, levoamphetamine, pseudoephedrine” 3.8.1.2 Identify the drugs substances screened for (and perhaps other information). The answer will be a “glob” of narrative text. “X” tested for:Prid:Pt:SYS:Nar:Screen (Answers = individual drugs that this screening test could detect, as a “blob” of text or canned comment) For example, Amphetamines tested for:Prid:Pt:Urine:Nar:Screen (narrative) Example answer = “The EMIT urine screen for amphetamines detects amphetamine, methamphetamine, dextroamphetamine, levoamphetamine as indications of methamphetamine abuse. It is also reactive with a component present in over-the-counter nasal decongestant inhalers, and a positive result must be confirmed by a quantitative method that rules out the non-abuse situation” When a screen is reported as negative, confirmatory testing is not performed. When a screening test is reported as positive, the result must be confirmed by an independent testing method. 3.8.1.3 Confirmatory testing for the presence of one or more members of the group represented as a single observation. “X”:PrThr:Pt:SYS:Ord:Confirm (Answers = present/absent) For example, Amphetamines:PrThr:Pt:Urine:Ord:Confirm Example answer: “present” 3.8.1.4 List of the actual drug/substances confirmed. “X” positive:Prid:Pt:SYS:Nom:Confirm (Answers = list of analytes detected) For example, Amphetamines positive:Prid:Pt:Urine:Nom:Confirm Example answer: “dextroamphetamine, methamphetamine” 46 LOINC® Users’ Guide - June 2016 3.8.1.5 More commonly, confirmatory testing is reported as a set of observations, one to report the presence (or quantitative amount detected) of each analyte in the group. “X”:PrThr:Pt:SYS:Ord:Confirm (Answers = present/absent) or “X”:MCnc:Pt:SYS:Qn:Confirm (Answers = quantitative amount) For example: Amphetamine:PrThr:Pt:Urine:Ord:Confirm [present] Dextroamphetamine:PrThr:Pt:Urine:Ord:Confirm [present] Methamphetamine:PrThr:Pt:Urine:Ord:Confirm [present] Levomethamphetamine:PrThr:Pt:Urine:Ord:Confirm [present] 3.8.2 Cutoffs The cutoff levels for screens and confirms of a given substance or group of substances will usually differ. There are three ways to indicate specific cutoffs in LOINC. 3.8.2.1 We provide separate LOINC terms for reporting the cutoff levels of a number of commonly abused substances and substance groups. “X” cutoff:MCnc:Pt:Urine:Qn:Screen “X” cutoff:MCnc:Pt:Urine:Qn:Confirm For example, Amphetamines cutoff:MCnc:Pt:Urine:Qn:Screen Example answer: “1000 ng/ml” For example, Methamphetamine cutoff:MCnc:Pt:Urine:Qn:Confirm Example answer: “500 ng/ml” 3.8.2.2 Two general cutoff terms, one for screen and one for confirm, can be applied to any substance whether or not a pre-coordinated term exists. XXX cutoff:MCnc:Pt:SYS:Qn:Screen XXX cutoff:MCnc:Pt:SYS:Qn:Confirm 3.8.2.3 For commonly used cutoffs, such as those mandated by regulatory agencies, we provided precoordinated terms for reporting a “present/absent” result with the cutoff specified in the method field: “X”:PrThr:Pt:SYS:Ord:Screen>“N” “X”:PrThr:Pt:SYS:Ord:Confirm>“N” For example, Amphetamines:PrThr:Pt:Urine:Ord:Screen>1000 ng/mL Example answer: “not detected” 3.8.3 Reporting the method used for screen and confirm We provide terms for reporting the method used for screen and confirm tests: 47 LOINC® Users’ Guide - June 2016 “X” screen method:Prid:Pt:SYS:Nom:* “X” confirm method:Prid:Pt:SYS:Nom:* These would normally be reported in conjunction with terms reporting levels and possibly cutoffs, as in the following example: Amphetamines:PrThr:Pt:Urine:Ord:Confirm [Answer = positive] Amphetamines cutoff:MCnc:Pt:Urine:Qn:Screen [Answer = 1000 ng/ml] Amphetamines screen method:Prid:Pt:Urine:Nom:* [Answer = EIA] Amphetamines positive:Prid:Pt:Urine:Nom:Confirm [Answer = amphetamine, methamphetamine] Amphetamine cutoff:MCnc:Pt:Urine:Qn:Confirm [Answer = 500 ng/ml] Methamphetamine cutoff:MCnc:Pt:Urine:Qn:Confirm [Answer = 500 ng/ml] Amphetamines confirm method:Prid:Pt:Urine:Nom:* [Answer = GC/MS] 3.8.4 Individual drug/metabolite test results Individual substances are typically reported as screens (ordinal), confirms (ordinal) or confirms (quantitative -- usually mass or substance concentrations), though some labs also report as screen (quantitative). Ordinal terms for reporting individual substances should always specify a Method of “screen” or “confirm.” Group test screens may be confirmed by group confirms (as described above) or by individual confirms (Either ordinal or quantitative-depending upon the laboratory's preference) 3.8.4.1 Individual test screen (ordinal) Methamphetamine:PrThr:Pt:Urine:Ord:Screen Example answer: “present” 3.8.4.2 Individual test screen (quantitative) Methadone:MCnc:Pt:Urine:Qn:Screen Example answer: “150 ng/ml” 3.8.4.3 Individual test confirm (ordinal) Methamphetamine:PrThr:Pt:Urine:Ord:Confirm Example answer: “present” 3.8.4.4 Individual test confirm (quantitative) Methamphetamine:MCnc:Pt:Urine:Qn:Confirm Example answer: “250 ng/ml” Individual tests may also be reported as simple quantitative (without confirm or screen), as is the case for 48 LOINC® Users’ Guide - June 2016 therapeutic drug level monitoring. 3.8.4.5 Individual substance measured quantitatively; screen/confirm is not relevant Digoxin:MCnc:Pt:Ser/Plas:Qn Example answer: “1.2 ng/ml” 3.8.5 Naming issues For confirms, you would always be looking for specific analytes. For example, you would never look for tetrahydrocannabinol, but would look for delta-9-tetrahydrocannabinol, 11-hydroxycannabinol, etc. 3.8.6 Summary For each “group” LOINC defines the following set of terms: “Analyte group”:PrThr:Pt:Urine:Ord:Screen “Analyte group”:PrThr:Pt:Urine:Ord:Confirm “Analyte group”:MCnc:Pt:Urine:Qn:Confirm “Analyte group” tested for:Prid:Pt:Urine:Nom:Screen “Analyte group” tested for:Prid:Pt:Urine:Nar:Screen “Analyte group” positive:Prid:Pt:Urine:Nom:Confirm “Analyte group” screen method:Prid:Pt:Urine:Nom:* “Analyte group” confirm method:Prid:Pt:Urine:Nom:* For each individual analyte LOINC now defines the following set of terms: Analyte:PrThr:Pt:Urine:Ord:Screen Analyte:PrThr:Pt:Urine:Ord:Confirm Analyte:MCnc:Pt:Urine:Qn:Confirm Analyte:MCnc:Pt:Urine:Qn Analyte cutoff:MCnc:Pt:Urine:Qn:Screen Analyte cutoff:MCnc:Pt:Urine:Qn:Confirm 3.9 Molecular Genetics LOINC Naming 3.9.1 Introduction Molecular pathology testing can be used for many purposes. In infectious disease testing to identify organisms and mutations in organisms; in genetic analysis to identify mutations including substitutions, deletions/insertions, frame shifts and trinucleotide repeats; to identify specific chromosomal translocation and clonality in leukemia and lymphomas; to identify various tumor associated genes and gene deletions; in paternity testing to determine the probability that a person is the parent of a child; and in forensic testing to determine the probability that a criminal is associated with genetic material he/she left as evidence. 25 LOINC term names follow the recommendations and nomenclature of other standards. As molecular genetic testing expands, we are evolving our naming conventions. Existing terms are being reviewed for 25 Antonarakis, SE, and the Nomenclature Working Group. Recommendations for a nomenclature system for human gene mutations. Human Mutation 1998;11:1-3. 49 LOINC® Users’ Guide - June 2016 compatibility with current naming conventions. An overall description of LOINC’s approach to naming molecular genetics tests can be found in the Deckard et al26 paper. 3.9.2 Brief review of molecular genetics terminology For clarity, here we provide a brief introduction to some key genetics terminology. DNA consists of a series of nucleotides, nucleotides encode amino acids, and a string of amino acids forms a protein. There are four types of nucleotides (adenine, guanine, cytosine and thymine), and a sequence of three nucleotides that codes for one amino acid is called a codon. Codons are numbered from the first codon participating in the protein (in humans the codon for Methionine) starting with codon number 1. Locus refers to a specific DNA (or RNA) codon or the corresponding amino acid produced by this codon. The string of DNA that codes for a protein is usually interrupted by DNA segments called introns, which do not contribute to the protein definition. The coding sequences of DNA between the introns are called exons. Linked together, the exons provide the instructions for creating the specific protein. Exons may be numbered e.g., exon 1, exon 2, etc. Exon numbers sometimes appear in the names of DNA mutations, but for a number of reasons, identifying codon locations relative to an exon is unreliable and we will try to avoid such nomenclature when possible in LOINC names. The term mutation is usually applied to a genetic variant that causes a functional change in the gene and results in disease. Genetic changes that occur during the life of the patient such as tumor mutation are called somatic and those that are inherited are referred to as germ line. The nature of the specimen and the testing usually distinguishes these two, so it is not necessary to include this distinction in the test names. Alleles refer to different forms of a gene and are distinguished at the phenotype level. The term allele is usually applied to a genetic variant that does not cause a disease. 3.9.3 Background on molecular genetics testing methods The main laboratory methods used are Southern Blot, which applies hybridization to selected DNA “chopped up” by restriction enzymes, Northern Blot, which applies hybridization to all cellular RNA (which comes naturally in smaller segments) and Restriction Fragment Length Polymorphism (RFLP). RFLP depends on the Variable Number of Tandem Repeats (VNTR), which are normal, but specific variants of each person’s DNA. Southern Blot may be combined with RFLP to target mutations whose exact gene molecular chemistry is not known. For completeness sake, we mention Western Blot, which applies an analogous blot method to protein analysis. In situ hybridization is a method that applies probes to intact tissue. The cellular patterns of the homologies can then be read microscopically. There are a variety of methods for detecting such in situ probes. One popular method is Fluorescent In-Situ Hybridization (FISH). This technique is analogous to an immune stain except that the molecular binding is based on DNA/RNA homologies instead of antigenantibody binding. DNA chips provide a radical new way to identify DNA and RNA sequences. In the patented AFYMETRIX® technique, the nucleoside chains are grown using lithography-like methods. Target DNA 26 Deckard J, McDonald CJ, Vreeman DJ. Supporting interoperability of genetic data with LOINC. J Am Med Inform Assoc. 2015 May;22(3):621-7. PubMed PMID: 25656513. 50 LOINC® Users’ Guide - June 2016 is tagged with a detector and “washed” over the chip in steps. The locations of the tags on the chip identify the DNA (RNA) in the sample. Identity testing is used to identify relationships among people and has special complexity. In paternity testing, it can be helpful to have DNA from the child, the putative father and the mother when possible to distinguish the alleles that come from the father. Forensic testing has special requirements of stringency and often mixes blood antigen testing with RFLP testing. The results are usually reported as a probability. 3.9.4 General molecular genetics naming rules LOINC’s approach to naming tests makes use of established conventions. For naming genetic tests that target specific genetic variations, LOINC uses the Human Genome Organization (HUGO) Gene Nomenclature Committee's (HGNC) terminology to name the gene(s) and Human Genome Variation Society's (HGVS, http://www.hgvs.org/mutnomen/) syntax to name the variation(s) of interest. HGVS provides four different levels of naming gene defects as described in Table 18. Table 18: Four types of nomenclatures for identifying the location of a genetic defect Designation p c g m Explanation Identify the defect by codon by counting the amino acids in the protein produced by the gene counting the first amino acid. Identify the defect by counting nucleotides from the messenger RNA used to produce the protein with introns excluded. Since three nucleotides = one codon, these will produce numbers 3x as large as those in the first method. Identify the defect by counting from the first nucleotide in the DNA for the gene of interest, as it exists natively in the chromosome with introns included. Identify the defect by counting from the first nucleotide in the full mitochondrial DNA sequence. The HGVS recommendations have evolved over time. In our early approach, we used the extant proteinbased naming convention to get the following name for the commonest mutation causing cystic fibrosis: CFTR gene.p.F508del:PrThr:Pt:Bld/Tiss:Ord:Molgen For clarity’s sake, HGVS now prefers the three letter amino acid abbreviations over the single letter amino acid abbreviations we used in the above example. We embrace the HGVS naming style for naming mutations at the amino acid level, but the world has not been consistently quick to adopt it. The old style, perhaps because of its brevity, persists. As we update existing codes to harmonize with current HGVS guidelines, we will make it easy for users to find our test names by including the old style as synonyms for the new style. Under the current HGVS rules, the above name would be: CFTR gene.p.Phe508del:PrThr:Pt:Bld/Tiss:Ord:Molgen Where we still report variants at the amino acid level, we use the nomenclature for human gene mutations proposed by Beaudet27 in the component or in the answer when the mutation is reported as an answer. A list of single and three letter amino acid codes are given in Table 19. 27 Beaudet AL, Tsui LC. A suggested nomenclature for designating mutations. Human Mutation 1993;2:245-248. 51 LOINC® Users’ Guide - June 2016 Table 19: List of single letter amino acid codes Amino Acid 1-Letter Symbol 3-Letter Symbol Alanine A Ala Arginine R Arg Asparagine N Asn Aspartic acid D Asp Cysteine C Cys Glutamic acid E Glu Glutamine Q Gln Pyroglutamic acid pQ pGlu Glycine G Gly Histidine H His Hydroxyproline, 4(R)-L- O Hyp Isoleucine I Ile Leucine L Leu Lysine K Lys Methionine M Met Phenylalanine F Phe Proline P Pro Serine S Ser Threonine T Thr Tryptophan W Trp Tyrosine Y Tyr Valine V Val Unknown X HGVS has made other changes in naming style. Overall they now prefer describing the variant at the coding DNA level as nucleotide changes rather than at the protein level as amino acid changes. The above cystic fibrosis mutation would have the following coding DNA-based name: CFTR gene.c.1521_1523del:PrThr:Pt:Bld/Tiss:Ord:Molgen For the nucleotide changes, they have adjusted the syntax for representing a change from one nucleotide string to another as # String1>String2 rather than String1 # String2, where # is an integer representing the nucleotide position of the variation. Another common cause of cystic fibrosis is a mutation that at the amino acid level would be named p.Gly551Asp with the new protein based naming convention, c.G1652A with the old DNA naming convention and c.1652G>A with the new coding DNA naming convention. (Realize, of course, that more than one nucleotide-level variation name can correspond to a single amino acid variation name). If clear guidelines are not in place for a given variant when a LOINC code is created, the familiar or common variant name may be used. LOINC will resort to using the disease name only when the gene has no name and/or the genetic defect is not yet fully specified. We will always include the genetic disease name in the related name field of the database when the disease name is not part of the component. This allows users to easily find the LOINC term by the disease name as well. 52 LOINC® Users’ Guide - June 2016 3.9.4.1 Specimens in molecular genetics Blood is the most common specimen for molecular pathology studies. Leukocytes, bone marrow, tumors, products of conception and forensic specimens also contain DNA and are important specimens. The system (specimen) used in the LOINC name for genetic testing will usually be Bld/Tiss since the distinction between these two specimens is rarely important to the result of a molecular pathology test. We have split this further to accommodate fetal specimens (Tiss^fetus). Other specimens include amniotic fluid, CVS, bone marrow, fixed tissue, and CSF. 3.9.4.2 Methods in molecular genetics In general, we do not create separate variables for each kind of molecular genetics method, (e.g., Southern Blot Northern Blot, PCR, restriction fragment length polymorphism (RFLP)) because the different methods do not provide significantly different results. Moreover, there are a plethora of minor method variants, and we would not be able to keep up with their proliferation. Therefore, instead we use a generic method of Molgen (for molecular genetics method) to indicate that a result of the analysis is based on a molecular genetics method rather than some chemical or antigen method. However, when results for a given molecular pathology technique are significantly different, we will distinguish the method. Examples of specific molecular pathology methods in LOINC include fluorescent in situ hybridization (FISH), sequencing, multiplex ligation probe amplification (MLPA), and microarray comparative genomic hybridization (arrCGH). 3.9.4.3 Narrative and document-level reporting in molecular genetics Bulk narrative reports in molecular pathology are often used to provide results for mutation analyses, without reporting any discrete coded answers. We discourage the use of this approach because it is not useful for automated analyses. Since these kinds of results often include some structured elements, we will use the Property “Find” and Scale “Doc” beginning with version 2.54. The scale of “Doc” represents a collection of information (e.g. results contained in a report) that are either structured or unstructured. To assist with structured reporting, we will attach to these terms specific associated observations that could be used to send data in a structured format. With this approach, labs will still have the flexibility to send text reports. However, we encourage them to also report key data as structured results using the associated observation variables so that it is more easily understood by computers. We plan to use this model for newly created terms for molecular pathology tests and, are contemplating the best approach for transitioning existing terms to this format over time. 3.9.5 Infectious diseases For most infections disease reporting, the existing LOINC nomenclature (e.g., detecting a particular species of organism by detecting DNA homology) works fine. The word DNA or RNA is included as part of the component name and we distinguish the type of method used for detecting the microorganisms (Probe, Probe.amp.tar, Non-probe.amp.tar, Probe.amp.sig). See the Microbiology section for more information. 53 LOINC® Users’ Guide - June 2016 3.9.6 3.9.6.1 Genetic conditions Diagnostic assays for the detection of specific mutations or variants We currently have at least four different styles for mutation analyses in LOINC: 1) Single mutation analysis: Diagnostic assays for the detection of a specific mutation or variant 2) Targeted mutation analysis: Diagnostic assays for a fixed set of the most common or important mutations 3) Known mutation analysis: Diagnostic assays for one or more mutations that have been previously identified in an affected family member 4) Full gene mutation analysis: Diagnostic assays usually done by sequencing of the entire coding region of a gene 3.9.6.1.1 Diagnostic assays for the detection of a specific mutation or variant When looking for one mutation, use LOINC’s single mutation style of gene name followed by the specification of the nomenclature (p, g, c, or m) and the mutation name. A dot will separate the gene name and the mutation identifier: <gene name> gene.<mutation nomenclature>.<mutation and its location> For example, Factor V Leiden mutation would be represented as F5 gene.p.R506Q. Where “F5” identifies the gene, “gene” is a fixed part, “p” identifies the kind of mutation nomenclature (protein) and “R506Q” indicates that the amino acid arginine (R) is replaced by glutamine (Q) (see Table 19) at codon #506. Some examples of fully specified LOINC names for tests of specific mutation are: F5 gene.p.R506Q: PrThr :Pt:Bld/Tiss:Ord:Molgen Synonyms = Factor V Leiden, Factor V resistance, APC resistance gene HFE gene.p.C282Y: PrThr :Pt:Bld/Tiss:Ord:Molgen Synonyms = HLA-H gene, hemochromatosis gene CFTR gene.p.F508 del:PrThr:Pt:Bld/Tiss:Ord:Molgen Synonyms = Cystic Fibrosis Transmembrane Regulator As mentioned above, HGVS now recommends the three letter amino acid abbreviations over the single letter amino acid abbreviations. As existing codes are updated, we will add synonyms for the old style to make it easy for users to find our test names. One type of testing procedure identifies a single mutation using two DNA probes: one for the normal locus and the other for the abnormal locus. When only the normal probe reacts, the laboratory reports “no mutation” or “wild type”. When both the normal and mutation probes react, the laboratory reports “heterozygous”. When only the mutation probe reacts it reports “homozygous”. Consequently, such single mutation testing produces one of three ordinal “answers”: a) no mutation (wild type) b) heterozygous mutation (the mutation found in one gene) 54 LOINC® Users’ Guide - June 2016 c) homozygous mutation (the mutation was found in both genes in the gene pair) Specific testing such as this is only possible when the molecular pathology of the gene is very well known and only one defect is being reported. Both document-level (scale is Doc) and ordinal (scale is Ord) codes are available in the LOINC database for single variant tests. In cases where more than one variant is tested, a nominal scale will be used. As mentioned above, we encourage the use of document-level codes for the order and overall result report, which can be used in conjunction with additional LOINC codes for reporting the discrete results. Results for specific mutations or variants may also be reported as two separate observations: one observation reports the kind of mutation (allele) found in the first chromosome and another for reporting the kind of mutation for the paired chromosome. In this case, the identity of the allele is reported in the answer. For example: APOE gene allele 1:Prid:Pt:Bld/Tiss:Nom:Molgen Answers = E2, E3, or E4 APOE gene allele 2:Prid:Pt:Bld/Tiss:Nom:Molgen Answers = E2, E3, or E4 3.9.6.1.2 Targeted mutation analysis LOINC’s approach to represent gene mutation analysis for many genetic variations within one or more genes has had the following form: <gene or disease name> targeted gene mutation analysis:Find;Pt:Bld/Tiss:Doc:Molgen For example: CFTR gene mutation analysis:Find:Pt:Bld/Tiss:Doc:Molgen Synonyms = Cystic fibrosis transmembrane regulator BRCA1 gene mutation analysis:Find:Pt:Bld/Tiss:Doc:Molgen Synonyms = breast cancer risk gene For each such targeted mutation analysis, we recommend reporting the mutations that were tested using an additional LOINC code, such as LOINC 36908-2 (Gene mutations tested for) or gene-specific companion LOINC observation codes with the words “mutations tested for”: <Gene or disease name> gene mutations tested for:Prid:Pt:Bld/Tiss:Nom:Molgen For example: CFTR gene mutations tested for:Prid:Pt:Bld/Tiss:Nom:Molgen The answers could include “Delta F508”, “G542X”, “R553X”, “W1282X”, “N1303K”, etc. The additional LOINC code is needed for reporting the mutation(s) that could have been found in a given analysis so that clinicians can know what was looked for when no abnormalities were found. The above gene mutation analysis terms could be used for ordering or reporting the results of a given targeted mutation analysis. Both document-level (scale is Doc) and nominal (scale is Nom) codes are available in the LOINC database. As mentioned above, we encourage the use of document-level codes for the order and overall result report, which can be used in conjunction with additional LOINC codes for 55 LOINC® Users’ Guide - June 2016 reporting the discrete results. Nominal results for such analyses could be: 1) no pathologic mutations found or 2) a list of individual mutations/variations found. When reporting discrete mutations as results, we propose using the HGVS nomenclature and including (in parentheses) the historic versions of the mutation names when such names exist. 3.9.6.1.3 Known mutation analysis The first two approaches are commonly called “targeted” mutation analyses, or looking for specific mutations within a given gene. Labs may offer testing for both targeted mutation analysis and analysis for known familial mutations. Known familial mutations are those previously identified within an affected family member. To distinguish these testing approaches, LOINC further defines testing for known familial mutations: <Gene name> gene mutation analysis limited to known familial mutations:Find:Pt:Bld/Tiss:Doc:Molgen For example: TNFRSF13B gene mutation analysis limited to known familial mutations:Find:Pt:Bld/Tiss:Doc:Molgen Since testing may involve more than one known mutation, especially for autosomal recessive conditions, LOINC uses the plural form of mutations in the Component. However, these terms also refer to testing for only one known familial mutation. 3.9.6.1.4 Full gene mutation analysis To describe mutation analysis by sequencing of the entire coding region of the gene, we use: TNFRSF13B gene full mutation analysis:Find:Pt:Bld/Tiss:Doc:Sequencing Here, we include the method of sequencing since this is a technique commonly used to identify mutations with the entire coding region of a gene. 3.9.6.2 Diagnostic assays for large deletions and/or duplications Detection of larger (>50 bp) genomic duplications or deletions is done by various techniques, including multiplex ligation-dependent probe amplifications (MLPA) and array-based comparative genomic hybridization (arrCGH). MLPA and aarCGH techniques detect gene dosage. To describe testing for large deletions and/or duplications (insertions) within a gene, we use: LDLR gene deletion+duplication:Prid:Pt:Bld/Tiss:Nar:MLPA In this case, we specify the method of multiplex ligation-dependent probe amplification (MLPA). MLPA is a common technique used to detect gene dosage of genomic deletions and duplications (e.g. one or more entire exons) and determine gene copy number. 3.9.6.3 Trinucleotide repeats A number of diseases, most of which manifest as neurologic disorders are caused by excessive repeats of 56 LOINC® Users’ Guide - June 2016 specific trinucleotides, and the age of onset of the disease is inversely proportional to the number of excess repeats. Examples of these disorders include: Fragile X syndrome Huntington disease Spinocerebellar ataxia (SCA1) We name the component of these terms by the gene when the gene is well defined or the disease, and the name of the trinucleotide that repeats plus the word “repeats”. <disease or gene name>.<trinucleotide> repeats For example, Huntington disease would be represented as HTT gene.CAG repeats Examples of some fully specified LOINC names are: FRAXE gene.CGG repeats:PrThr:Pt:Bld/Tiss:Ord:Molgen Synonym = Fragile x syndrome HTT gene.CAG repeats:PrThr:Pt:Bld/Tiss:Ord:Molgen Synonym = Huntington Disease, It15, HD, Huntington Chorea Spinocerebellar ataxia genes.CAG repeats:PrThr:Pt:Bld/Tiss:Ord:Molgen DMPK gene.CTG repeats:PrThr:Pt:Bld/Tiss:Ord:Molgen Synonym = Myotonic Dystrophy These are usually reported “not expanded”, “indeterminate” or “expanded”, so the scale is Ord. When the actual number of trinucleotide repeats is reported, the property is entitic number (EntNum) and the scale is quantitative (Qn), and separate results are reported for each allele. Examples include: HTT gene allele 1.CAG repeats:EntNum:Pt:Bld/Tiss:Qn:Molgen HTT gene allele 2.CAG repeats:EntNum:Pt:Bld/Tiss:Qn:Molgen DMPK gene allele 1.CTG repeats:EntNum:Pt:Bld/Tiss:Qn:Molgen DMPK gene allele 2.CTG repeats:EntNum:Pt:Bld/Tiss:Qn:Molgen 3.9.6.4 Hematopathology gene re-arrangement. Immune cells have an innate genetic variability due to rearrangement. The unique rearrangement can be used to identify the development of a clone of one cell type as occurs in many lymph cell tumors (e.g., lymphoma). We use the following format to identify clonal excess. Immunoglobulin heavy chain gene rearrangements:Arb:Pt:Bld/Tiss:Ord:Molgen Immunoglobulin kappa light chain gene rearrangements:Arb:Pt:Bld/Tiss:Ord:Molgen Immunoglobulin lambda light chain gene rearrangements:Arb:Pt:Bld/Tiss:Ord:Molgen TCRB gene rearrangements:Arb:Pt:Bld/Tiss:Ord:Molgen Synonym = T cell receptor beta chain TCRD gene rearrangements:Arb:Pt:Bld/Tiss:Ord:Molgen Synonym = T cell receptor delta chain TCRG gene rearrangements:Arb:Pt:Bld/Tiss:Ord:Molgen Synonym = T cell receptor gamma chain 57 LOINC® Users’ Guide - June 2016 These would be reported as “clonal” or “not clonal”. 3.9.6.5 Chromosomal alterations: translocations, deletions, and inversions LOINC nomenclature follows the International System for Human Cytogenetic Nomenclature (ISCN) guidelines when describing chromosomal alterations, including translocations, large deletions and inversions. Tests to detect fused genes or transcripts (RNA, cDNA) due to a chromosomal alteration are designated as follows: t(<Chromosome of breakpoint gene 1>;<Chromosome of breakpoint gene 2>)(<Location on chromosome 1>; <Location on chromosome 2)(<gene1>,<gene2>) fusion transcript For example: t(9;22)(q34.1;q11)(ABL1,BCR) fusion transcript:Arb:Pt:Bld/Tiss:Ord:Molgen Synonyms = Philadelphia chromosome, BCR1, chronic myeloid leukemia, CML t(14;18)(q32;q21.3)(IGH,BCL2) fusion transcript:Arb:Pt:Bld/Tiss:Ord:Molgen Synonyms = Follicular B cell lymphoma, oncogene B-cell leukemia 2, CLL, chronic lymphatic leukemia, follicular lymphoma t(15;17)(q24.1;q21.1)(PML,RARA) fusion transcript:Arb:Pt:Bld/Tiss:Ord:Molgen Synonyms = RAR, promyelocytic leukemia, myelogenous, retinoic acid receptor, acute promyelocytic leukemia, APL For chromosomal deletions and inversion,‘t’ above would be replace with ‘del’ or ‘inv’, respectively: del(1)(p32p32)(STIL,TAL1) fusion transcript:PrThr:Pt:Bld/Tiss:Ord:Molgen Synonyms = SCL/TAL1 interrupting locus, T-cell acute lymphoblastic leukemia, ALL, T-ALL, TAL-1 deletions inv(16)(p13.1;q22.1)(MYH11,CBFB) fusion transcript:Arb:Pt:Bld/Tiss:Ord:Molgen Synonyms = inversion 16, AML, Acute myeloid leukemia In some cases, testing may involve comparing the fused transcript to a control transcript and results may be reported as a number ratio (NRto), log number ratio (LnRto), or relative ratio (RelRto): t(9;22)(q34.1;q11)(ABL1,BCR) fusion transcript/control transcript:NRto:Pt:Bld/Tiss:Ord:Molgen t(9;22)(q34.1;q11)(ABL1,BCR) fusion transcript/control transcript:LnRto:Pt:Bld/Tiss:Ord:Molgen t(9;22)(q34.1;q11)(ABL1,BCR) b3a2 fusion transcript/control transcript (International Scale):RelRto:Pt:Bld/Tiss:Ord:Molgen To specify “major” or “minor” breakpoints, we use: t(9;22)(q34.1;q11)(ABL1,BCR) fusion transcript major break points:Arb:Pt:Bld/Tiss:Ord:Molgen t(9;22)(q34.1;q11)(ABL1,BCR) fusion transcript minor break points:Arb:Pt:Bld/Tiss:Ord:Molgen To specify specific breakpoints, we use: t(9;22)(q34.1;q11)(ABL1,BCR) b2a2+b3a2 fusion transcript:Arb:Pt:Bld/Tiss:Ord:Molgen Synonyms = major breakpoints, p210, e13a2, e14a2, t(15;17)(q24.1;q21.1)(PML,RARA) bcr1 fusion transcript:Arb:Pt:Bld/Tiss:Ord:Molgen Synonyms = breakpoint cluster region 1, long form 58 LOINC® Users’ Guide - June 2016 Translocation terms can also be expressed as a fraction of cells that have the rearrangement versus total cells of interest: Cells.t(9;22)(q34.1;q11)(ABL1,BCR)/Cells.total:NFr:Pt:Bld/Tiss:Qn:Molgen If specific partner genes are not known, we use the pattern: CCND1 gene rearrangements:Arb:Pt:Bld/Tiss:Ord:Molgen Synonyms = Lymphoma 1 BCL2 gene rearrangements:Arb:Pt:Bld/Tiss:Ord:Molgen Synonyms = Lymphoma 2 3.9.7 Identity testing The identity testers usually look at 4 genetic loci (each locus is polymorphic enough that any one match has a 10% error of being incorrect). The loci are independent so if all 4 probes match (including all exclusions and inclusions) the probability of an erroneously match is .0001 (one out of 10,000). They may use more than four depending upon the degree of confidence required by the circumstances of the testing. The forensic community chooses from a set of about 20 probes. We propose two styles for reporting identity testing: atomic and pre-coordinated definitions. 3.9.7.1 Atomic style This style uses a series of LOINC names to report the kind of index case, the kind of comparison case, the results of the identity testing, and all of the other separate components of the testing. It includes an observation for reporting the actual probes used, and another observation for reporting the population that the probes assume. The method will be MOLGEN.IDENTITY.TESTING. For example: DNA probes used:Prid:Pt:Index case^comparison case:Nom: Molgen.identity.testing Population base:Prid:Pt:Probes:Nom: Molgen.identity.testing Relationship:Type:Pt:index case:Nom: Molgen.identity.testing Answers = child, victim, suspect Relationship:Type:Pt:^comparison case:Nom: Molgen.identity.testing Answers = mother, alleged mother, father, alleged father, evidence (external to victim) Confidence of relationship:likelihood:Pt:Index case^comparison case:QN: Molgen.identity.testing (gives the statistical confidence in the conclusion) Conclusion:Imp:Pt:index case^comparison case:Nar: Molgen.identity.testing (gives a summary statement of the conclusion about identity of relatedness) 3.9.7.2 Pre-coordinated definitions alternative Some of the above atomic terms (e.g., DNA probes used) could also be reported with the pre-coordinated results. Relationship:likelihood: child^alleged mother:Qn:Molgen.identity.testing Synonyms= maternity testing 59 LOINC® Users’ Guide - June 2016 (gives the likelihood that the alleged mother is the mother of the index child) Relationship:likelihood:child^alleged father:Qn:Molgen.identity.testing Synonyms = paternity testing (gives the likelihood that the alleged father is the father of the index child) Relationship:likelihood: victim^suspect:Qn:Molgen.identity.testing (gives the likelihood that the genetic material on the victim is that of the suspect) Relationship:likelihood: suspect^victim:Qn:Molgen.identity.testing (gives the likelihood that the genetic material on the suspect is that of the victim) Identity:likelihood:Evidence^suspect:Qn:Molgen.identity.testing (gives the likelihood that the genetic material on the evidence is that of the suspect) Identity:likelihood:evidence^victim:Qn:Molgen.identity.testing (gives the likelihood that the genetic material on the evidence is that of the victim) Tumor related genetics Using the models described in this section, LOINC has terms for many genetic tests relevant to cancer, including tests related to tumor suppressor genes (e.g. BRCA1, BRCA2, and p53), oncogenes (e.g. HER2), and more. 3.10 HLA allele and antigen nomenclature Naming conventions for HLA alleles and antigens are specified by the WHO Nomenclature Committee for Factors of the HLA System. Recommendations for both allele and antigen naming have evolved since the original HLA terms were represented in LOINC. For the LOINC 2.54 release (December 2015), we updated nearly all of the antigen and allele terms to reflect the WHO Nomenclature Committee’s latest recommendations. HLA allele and antigen naming conventions are briefly described below; for more details, see http://hla.alleles.org/. Allele names begin with the “HLA-” prefix and gene name, followed by an asterisk (e.g. “HLA-A* or HLA-DR*”) and up to four sets of numbers separated by colons. The first set of digits following the asterisk describes the allele type, which may correspond to the serological antigen number (e.g., “HLAA*01 corresponds to the antigen HLA-A1). The second set of digits is the subtype number, which is assigned in the order in which the subtype was identified and sequenced. The third and fourth sets of digits describe the specific sequence variations of the subtype if applicable. Antigen names also begin with the “HLA-“ prefix and specific gene, but antigen names are distinguished from allele names in that the gene name is not followed by an asterisk. For HLA-A, -B, -DQ and –DR, the antigen number immediately follows the gene name, and HLA-C, -D and -DP have a lower case w between the gene name and the antigen number (e.g., HLA-Cw3). The lower case w is used to distinguish the C antigens from complement factors and the D and DP antigens as being identified by cellular techniques rather than serological ones. Most antigen names have one set of digits (the antigen number) following the gene name, but in some cases, if an antigen originally identified as a single antigen was later recognized as being two distinct entities, the original, broader antigen number will follow the specific number in parentheses. For example, HLA-B38(16) and HLA-B39(16). 3.11 Allergy Testing The allergy testing industry provides tests for more than 450 different allergens today. Most testing detects IgE antibodies against these allergens. For some allergens testing for IgG and IgA antibodies are available, as well. 60 LOINC® Users’ Guide - June 2016 For LOINC terms that represent allergen testing, the component is the allergen name plus the type of the antibody (mostly IgE). Most allergens relate to animals, plants or derivatives of such entities. In the past (prior to LOINC vs. 2.04), we used the common name, rather than the scientific name to identify the allergen. However, this approach led to some duplicate term definitions, because two different companies would name the same allergen differently. It also led to ambiguity because two different species of animal or plant would sometimes have the same common name. As of version 2.04, we corrected these problems. To help reduce the ambiguity we now use the Latin name of the species of the biologic entity that causes the allergy. Some background: First, most allergens can also be identified with a special 2-5 character code assigned by Pharmacia28 that most allergy testing companies reference in their catalogue of testing. We used these codes to identify duplicate and ambiguous LOINC allergy test terms. These Pharmacia codes are also included in the related names field of the database. Second, allergen tests are often reported in two styles: a quantitative raw measure and an ordinal (0-6) severity rank (RAST class). LOINC defines separate terms for each of these reporting styles. For example, the two LOINC codes for reporting IgE antibodies to Japanese Millet are: Echinochloa crus-galli Ab.IgE:ACnc:Pt:Ser:Qn Echinochloa crus-galli Ab.IgE.RAST class:ACnc:Pt:Ser:Ord The RAST class is a categorization of the raw measurement based on specific allergy criteria. The specific IgE class result values (0, 1, 2, 3, 4, 5, or 6) are an ordered categorical response rather than a continuous numeric scale, therefore “RAST class” terms have an ordinal (ORD) scale. Laboratories also test mixtures of allergens to produce one result. These will be represented in LOINC as follows: (Acer negundo+Quercus alba+Ulmus americana+Populus deltoides+Carya pecan) Ab.IgE:ACnc:Pt:Ser:Ord:Multidisk Related name = tx2 There may be more than one type of allergen for each plant. For instance, IgE antibodies can develop towards tree pollen and the fruit of the same tree. Similarly, antibodies exist for grain and for grain pollen. In these cases, the LOINC component will contain the word “POLLEN” to distinguish the pollen allergen from the food allergen. For example, the LOINC term for corn (maize) IgE antibody would be: Zea mays Ab.IgE:ACnc:Pt:Ser:Qn: Related names = f8; cultivated corn; maize Zea mays pollen Ab.IgE:ACnc:Pt:Ser:Qn Related names: g202: cultivated corn; maize Naming rules for allergens The component (analyte) for an allergen consists of the name of the biologic organism that is the source of the allergen. The formal name will use the Latin taxonomic name e.g. Arachis hypogaea. The long common name will use the common name of that entity, e.g. Peanut, if one exists. In the case of very well specified allergens, the component will also indicate whether the allergen has a natural source or has been generated via recombinant method by adding the word, "native" or "recombinant, respectively. Different antigens from the same species are distinguished by the addition of a sequence number that roughly reflects when in time they were identified. 28 ImmunoCAP Allergens [Internet]. Uppsala(Sweden): ImmunoCAP; c2006 [updated 2007 November 2; cited 2008 June]. Available from: http://www.immunocapinvitrosight.com/ . 61 LOINC® Users’ Guide - June 2016 So you will see names that contain content like : Arachis hypogaea recombinant 1 Arachis hypogaea recombinant 3 Arachis hypogaea native 1 Arachis hypogaea native 3 However, as is true in other classes of LOINC, we sometimes embed synonyms within the allergen analyte name to help users recognize the term by their naming rules. Using the LOINC wide convention, synonyms are enclosed in parentheses and immediately follow the word or words which they represent. We insert standard acronym names used by most allergen manufacturers as synonyms. These begin with lower case "n" or "r" to distinguish native from recombinant allergens followed by the first 3 letters of the genus (in Latin), a space and the first letter of the species (in Latin). If the first 3 letters of the genus and the first letter of the species are not enough to distinguish between two allergens, the second letter of the species name is added (e.g., Prunus avium recombinant (rPru av) 1). Because the content in the parentheses represents the antigen acronym and not the Pharmacia code, the antigen sequence number is purposely placed after the closed parenthesis. Of course we also append Ab.IgE to the end of this entity name. Putting this all together formal and common name for the component for the allergens listed above become: LOINC code 58779-0 58777-4 65769-2 65771-8 4 Formal name of component Arachis hypogaea recombinant (rAra h) 1 Ab.IgE Arachis hypogaea recombinant (rAra h) 3 Ab.IgE Arachis hypogaea native (nAra h) 1 Ab.IgE Arachis hypogaea native (nAra h) 3 Ab.IgE Long common name of component Peanut recombinant (rAra h) 1 IgE Ab Peanut recombinant (rAra h) 3 IgE Ab Peanut native (nAra h) 1 IgE Ab Peanut native (nAra h) 3 IgE Ab Clinical observations and measures 4.1 Introduction For most of the measures we include separate observations for summary data, e.g., shift and 24-hour urine output totals. We also provide varying degrees of pre-coordination for the observation, the body site at which it was obtained, and the method. For example, a cardiac output based on the Fick method is distinguished from a cardiac output computed from 2D cardiac echo data. Physiologic measures are often monitored continuously over time and the instrument reports summary “statistics” over that reporting period. For vital signs these can include minimum, maximum, and mean value over a time period. For intake and output the total is the summary statistic usually reported. When we address measures taken over time, we usually include 1 hour, 8 hour, 10 hour, 12 hour, and 24 hour intervals to cover the varying lengths of work shifts within and across institutions. The LOINC names of these correspond to the form of a 24-hour urine specimen. The times are recorded in the duration (third part) of the name. The parts of clinical measurement names are largely the same as for laboratory measures, with some subtle differences that are detailed below. Parts 2, 3, 5 and 6 (type of property, timing, scale, and method) correspond exactly in meaning between 62 LOINC® Users’ Guide - June 2016 laboratory and clinical LOINC codes. System: Part 4, body system, has the same general meaning for clinical and laboratory measures, but whereas in the case of laboratory tests the system usually identifies a fluid and a body compartment by implication (e.g., serum, cerebral spinal fluid), for clinical terms, the system is usually a body part (e.g., chest), organ (e.g., heart), or part of an organ (e.g., heart.ventricle). In some cases the system may be an instrument or device attached to the system (e.g., OB ultrasound imaging device). Component: In the case of laboratory test observations, the component (part 1) usually identifies some chemical moiety that is distributed in the system (glucose, or HIV antibodies). In the case of clinical terms, the component usually identifies a particular projection of a three or four dimension space to a measure of a particular feature (e.g., QRS interval, systolic) of a time changing measure (ventricle.left.outflow tract). In addition, the component is used to distinguish the various ranges or inflections of a physiologic tracing, or to define precisely the section in three-dimensional space in which an area or range is being measured. The component includes such things as the special kinds of length (e.g., circumference, diameter, or radius) when length is the property, and the specific level and axis on which a measurement of a body part is taken, e.g., circumference taken at the nipple line. The component should remove all ambiguity as to what projection or axis or specific sub-time frame is being measured. So if one is measuring the diameter of the kidney, the system would have to specify kidney.right (or kidney.left), and the component would identify the axis and level at which the diameter was measured (e.g., cross-sectional at level of pelvis). For a measure of chest circumference the system = chest, the component = circumference at nipple line, and the property = length. Areas, lengths, and volumes of organs all have to be specified enough in the component to distinguish a particular area or length that is being measured. When a measure changes over some cycle (e.g., inspiration, expiration, diastole, and systole), then that should also be specified in the component. (Duration is used to identify the duration of an overall study.) For most clinical measurements, the component is an attribute of a patient or an organ system within a patient. However, attributes of non-patient systems are also often of interest. For example, we might want to know the class of instrument used to obtain the measurement: i.e., the vendor model number or institutional inventory number of an endoscopy. Such identification numbers have a property of ID. Infection control might want the latter reported in order to track nosocomial infections. When attributes of an instrument or device are being reported, the system is the name of the instrument. The same is true when we report characteristics of tubes used to move fluid in and out of body cavities. For example, we might want to report the size and type of a nasogastric tube. Table 20: Example subjects covered in clinical LOINC Body pressure (systolic, diastolic, and mean) Body measurements Body weight (and measures used to estimate ideal body weight) Cardiac ultrasound Cardiac output, resistance, stroke work, ejection, fraction, etc. Circumference of chest, thighs, legs Critical care measures Dental Electrocardiographic measures 63 LOINC® Users’ Guide - June 2016 Emergency department case reports (CDC DEEDS) Gastroenterology endoscopy Heart rate (and character of the pulse wave) Intake and output Major headings in operative note Major headings in discharge summary Major headings of history and physical Obstetric ultrasound imaging Ophthalmology measurements Pathology protocols Pulmonary ventilator management Radiology reports Respiratory rate Standardization survey instruments Urology ultrasound imaging To accommodate the special dimensions of clinical observations we have introduced new options for the kind of property. The new kinds of property are what you might expect from the new kinds of dimensions being measured (e.g., resistance, voltage, work per beat). However, we have also introduced three important new properties: Anat Anatomic is a special case of Prid that identifies anatomic sites. Imp Impression is a diagnostic statement, always an interpretation or abstraction of some other observation (a series of test results, an image, or a total patient), and almost always generated by a professional. (We could also consider the EKG cart's automated diagnoses as impressions.) Impressions are used in laboratory medicine as well as clinical medicine, so you will see them appearing there as well. Find Finding is an atomic clinical observation, not a summary statement as an impression. Physical, review of systems and other such observations have a property of Finding. These may have a scale of Nom for coded findings, Nar for findings reported in narrative text or Ord for ordinal findings. Hx Terms representing patient or family history concepts originally had Components that began with “History of” and were assigned the Find property. As of LOINC version 2.56, these terms were updated to remove “History of” from the Component and change the Property to Hx, which is exactly what this Property represents. In clinical measures, super systems (the second subpart of the system component) may be required. For example, we distinguish head measures of a patient versus a fetus as follows: Circumference.occipital-frontal:Len:Pt:Head:Qn Diameter.biparietal:Len:Pt:Head^fetus:Qn 4.2 Atomic versus molecular (pre-coordinated names) 64 LOINC® Users’ Guide - June 2016 With clinical terms we almost always have two ways of reporting. Using the first, we can report an observation by reporting a number of atomic variables which together fully describe the observation. For example, we have the following atomic observations for circumference measures. These variables let us deal with all of the unique kinds of circumferences for which we have not yet defined a pre-coordinated term. Table 21: Examples of Pre-Coordinated Names Code Description Circumference:Len:Pt:XXX:Qn The actual measure of some circumference Identifies the body part measured (specifies the system) Identifies the measuring technique used to obtain the circumference (answers = tape measure, derived, imaging) Circumference site:Anat:Pt:*:Nom Circumference method:Type:Pt:XXX:Nom:* We also provide pre-coordinated terms that combine some of the atomic variables into one LOINC code. For example, we have: 8279-2 Circumference.at nipple line:Len:Pt:Chest:Qn and 8293-3 Circumference^inspiration:Len:Pt:Chest:Qn which provide more specificity and permit the key components of the measure to be expressed as one variable as is the convention in many clinical systems. We call these pre-coordinated codes “molecular” variables. Within the LOINC database molecular variables will vary with respect to how many atomic components are aggregated. As is true in some laboratory areas, methods often are not included as part of a name, nor are they always reported. The most common molecular aggregation is between functional measure and a particular site of measurement. (e.g., the many different intravascular sites for blood pressure measurements.) But in some cases the molecular variables represent combinations of specific measures and particular methods (e.g., the cardiac output measures). Please note that most molecular variables could also be accompanied by one or more atomic measures to provide special information about the measure, e.g., special circumstances of the measure, or the vendor model number or institutional inventory number of the measuring instrument. When we have a variable that really reports what would have been contained in the name in a fully pre-coordinated term, we will place an asterisk in the part that will be reported as a value. For example, a variable that is used to report the anatomic site as an atomic variable, would have an asterisk (*) in the system part of the name. The variable used to report the method of a particular measure would have an asterisk (*) in the method part of the name. 4.3 Radiology Reports The creation of LOINC codes for naming radiology reports began with a special subgroup of committee members and a collection of report names from a variety of clinical sites. Radiology LOINC codes were first released in 2000. A bolus of over 2,000 new codes was added in December 2004, and the Radiology section of LOINC continues to be an active area of growth. 65 LOINC® Users’ Guide - June 2016 LOINC names for radiology reports follow the general pattern of other clinical observations and measures, with some subtle differences noted below. Parts, 2, 3, and 5 (type of property, timing, and scale) correspond exactly in meaning to other clinical and laboratory LOINC codes. 4.3.1 In-progress changes coming through our collaboration with the RSNA Through our collaboration with the Radiological Society of North America (RSNA), we are jointly reviewing and unifying our models for naming radiology study terms. Beginning with the June 2015 release and in subsequent releases, LOINC users can expect some significant changes to the naming conventions used. We began our work with computed tomography terms, and are in the process of extending the model to other modalities over time. The collaboration effort has produced a unified model for naming radiology procedures. That new model is included in this document as Annex - RadLex-LOINC Radiology Playbook User Guide. For example, one of the new features of the unified model is an attribute that allows for both the region imaged and a specific structure that is the focus of imaging, e.g., a CT of abdomen with special attention to the pancreas. The syntax used to describe the Anatomic Location attribute is as follows: [<body region imaged>] {“+” <body region imaged>} [“>” <imaging focus>] If there is a single anatomic context associated with a code, it should be specified as <body region imaged>. The <imaging focus> is an optional element that can identify a more specific anatomic context. We have now migrated the representation of existing LOINC CT, MR, US, NM and PT terms into this pattern. By the time the unification effort is complete, we expect to update most of the contents of this whole Radiology section with that new guide that describes the unified model in detail. Until then, some domains of content may be in transition between the old models and the new one. For this reason, we have left contents of the prior Radiology naming conventions here. In addition, our detailed review of the radiology terms in both RadLex and LOINC has detected several terms that are ambiguous, erroneous, or of questionable utility. Following our usual editorial policies, these terms will be discouraged or deprecated as appropriate. We anticipate that additional curation will follow as we progress our modeling efforts to the other modalities. 4.3.2 4.3.2.1 Diagnostic Radiology Reports Component Like other clinical LOINC codes, the component identifies a particular projection of a three dimensional space. The component should remove all ambiguity about what projection is being measured. a) Component/Analyte name The first subpart of the component field delineates the projections and spatial conditions that are present during image acquisition. The first subpart is named using the syntax: 66 LOINC® Users’ Guide - June 2016 <descriptor> [<number of views>] [<projection beam orientation>] [<body position>] The <descriptor> identifies the type of images in the report. For diagnostic x-ray and mammography studies, the <descriptor> is either View or Views. For diagnostic ultrasound, MRI, CT, and tomography studies, the <descriptor> is Multisection. The descriptor is the only required field in the component. Where it is appropriate, additional words are added to the first subpart of the component to clarify the focus of the exam (e.g., Multisection limited, or Multisection for pyloric stenosis). The <number of views> is an optional parameter to describe a specific integer number of views in the projection. Many radiology report names do not specify the actual projections taken, but rather only the number of views. Some report names describe the number of views in relative terms like “minimum of 3 views” or “less than 4 views”. Where necessary to specify these relative qualifications, we use the following expressions: * Gt = greater than * Ge = greater than or equal to * Lt = less than * Le = less than or equal to The <projection beam orientation> is an optional parameter that specifies the orientation(s) of the beam with respect to the patient. Widely used abbreviations with unambiguous meanings are employed where appropriate (e.g., PA, AP, etc.). Multiple images with different orientations are combined using “&”. The <body position> is an optional parameter to remove ambiguity about the subject’s body position with respect to gravity. Examples positions include prone, upright, supine, for example: View PA prone:Find:Pt:Abdomen:Doc:XR In order to accommodate special groupings of views and challenges, where necessary, we will make an exception to the principle of not using parentheses in the component for radiology studies (see section 2.1.3). For example: Views (AP^standing) & (lateral^W hyperextension):Find:Pt:Knee:Doc:XR b) Report names for portable studies In general, we do not make names for reports of portable studies, except when the image produced by a portable study is different than the normal study. For example, portable chest x-ray studies are typically taken at a shorter distance than those taken in the radiology department, and thus we create separate LOINC codes for them: Views AP portable:Find:Pt:Chest:Doc:XR c) Eponyms and colloquial expressions Radiology tests are often commonly referred to by eponyms or colloquial expressions. When they are widely used and understood, these names can represent a concise way to communicate the test(s) being reported. In many cases, these expressions convey meaning that spans multiple parameters or even multiple LOINC axes (e.g., COMPONENT, METHOD, and SYSTEM). LOINC names typically employ these expressions only when their meaning is unambiguous, and confine the use of these expressions within one axis. For example: 67 LOINC® Users’ Guide - June 2016 View Merchants:Find:Pt:Knee:Doc:XR d) Challenge tests The second subpart of the component is chemical, physical, and/or functional challenges. The naming convention for chemical challenges (e.g., administration of contrast agents) follows the previously described pattern, including abbreviations for route of administration. For example: Multisection^ WO & W contrast IV:Find:Pt:Kidney.bilateral+Collecting system:Doc:XR.tomo When describing administration of contrast into specific spaces for which abbreviations do not exist, the space is spelled out in full, and preceded by “intra” or “via” according to these guidelines: We use “intra” when the contrast injected goes directly into this anatomic space, and this space is what is visualized in the study. For example: Views^W contrast intra lymphatic:Find:Pt:Lymphatics:Doc:XR.fluor We use “via” when the contrast injected goes through this device (e.g., catheter) and into the anatomic space being visualized. For example: Views^W contrast via T-tube:Find:Pt:Biliary ducts+Gallbladder:Doc:XR.fluor Views^W contrast via colostomy:Find:Pt:Colon: Doc:XR.fluor Physical challenges that are present during imaging are denoted using a similar pattern: [<existence>] <challenge> where existence is denoted W, WO, or WO & W. The existence of WO & W denotes separate views, without and with the challenge. For example: Views^WO & W weight:Find:Pt:Acromioclavicular joint:Doc:XR 4.3.2.1.1 Ambiguity related to “decubitus” in radiology projections and positions This section describes several issues surrounding radiology naming conventions involving the term “decubitus” in abdomen and chest x-ray terms, and to describe an LOINC’s accepted naming conventions. The primary point of confusion concerns an ambiguous naming convention that mixes projection and body position. 4.3.2.1.1.1 Accepted Term Definitions Excerpts from Merrill’s Atlas of Radiographic Positions and Radiologic Procedures29: a) Decubitus Indicates that the patient is lying down and that the central ray is horizontal and parallel with the floor. 29 Ballinger PW, Frank ED. 10th ed. Vol. 3 Merrill’s atlas of radiographic positions and radiographic procedures. St. Louis:Elsevier Mosby; 2003. 68 LOINC® Users’ Guide - June 2016 Three decubitus positions are named according to the body surface on which the patient is lying: (i) Lateral decubitus (left or right) In a lateral decubitus position, the patient is side-lying. The position is named left or right by the side of the patient lying on the table. If the patient’s back is closest to the IR (image receptor, e.g., unexposed x-ray film), this resulting projection is AP. If the patient’s ventral surface (stomach) is closest to the IR, the resulting projection is PA. The AP projection in the left lateral decubitus position is the most common (and perhaps implied) decubitus view. However, it is also possible to do a lateral projection in a right or left lateral decubitus (recumbent) position. (Figure 16-17, Merrill, Vol. 3) The lateral decubitus position is most often used to demonstrate the presence of air-fluid levels or free air in the chest or abdomen because air rises to the right side and views, are not obliterated by air that may be in the stomach. ii) Dorsal decubitus In a dorsal decubitus position, the patient is supine. The central ray provides a lateral projection. The position can be named left or right by the side of the patient that is closest to the IR. This is also called a cross-table lateral view (abdomen). This type of position is commonly used in lateral x rays of the spine when the patient cannot be moved into a standard lateral position and premature infants that cannot be positioned easily. iii) Ventral decubitus In a ventral decubitus position, the patient is prone; rarely performed, usually in cases of trauma when the patient cannot be moved. The central ray provides a lateral projection. The position can be named left or right by the side of the patient that is closest to the IR. b) KUB The Kidneys, Ureters, Bladder (KUB) imaging technique is an Abdomen AP projection, often with the patient in the supine position. The KUB view includes anatomical structures from the diaphragm to the symphysis pubis. 4.3.2.1.1.2 Radiology Naming Conventions In Radiology, LOINC has typically allowed several levels of granularity to accommodate differences in naming conventions (e.g., specifying laterality or not, explicitly specifying contrast use or not). Different levels of granularity have been observed in this domain as well. 69 LOINC® Users’ Guide - June 2016 Example local term names: • • • • • • Abd R Lat Decub XR Abd R Decub Port XR Abdomen Decubitus Chest Decub XR Chest L Decub XR Xray Chest Decubitus 4.3.2.1.1.2.1 Decubitus is a body position, not a projection. To add clarity to the names, we will use decubitus only to refer to the lateral decubitus position. a) When using decubitus to specify body position, we will explicitly say “L-lateral-decubitus” or “Rlateral-decubitus”. Including the word “lateral” adds clarity as to which projection we are talking about, and the dashes “-” help link the words together. (i) Where the intent is to not name a side, we will use “lateral-decubitus”, rather than the more ambiguous, naked “decubitus”. 4.3.2.1.1.2.2 We will not use the term “dorsal decubitus” to refer to the supine position. Supine will be used as a valid body position where needed. a) Because it is common and clear, we use “lateral crosstable” to mean a lateral projection (right or left) in the supine position, thus encompassing both a projection and body position. 4.3.2.1.1.2.3 The term “ventral decubitus” will not be used to refer to the prone position. Instead, we use prone as a valid body position where needed. 4.3.2.1.1.2.4 Historically, we created some terms in which there was an implied projection (e.g., AP). Through careful review, we revised or deprecated these ambiguous terms so as to make the particular projection explicit include in the name. a) When a particular projection is not named, it is implied that any potential projection could be done/reported with this code (e.g., AP, PA, or lateral). b) An AP L-lateral-decubitus and AP R-lateral-decubitus are considered distinct “views” in our naming conventions. Thus, use plural “views” and not the singular “view” in such terms. c) A naked “lateral” in the component means a lateral projection (in any body position). d) Historically, LOINC included some terms with the abbreviation KUB as a named view. Through careful review, we have discontinued its use in favor of simply using the projection (AP) and a specified patient position (e.g., supine or upright) where necessary. This avoids the ambiguity about what KUB means with respect to the patient position. e) As in other areas tricky spots of Radiology names, parentheses will clarify which projections are 70 LOINC® Users’ Guide - June 2016 being done in which body positions. 4.3.2.2 Timing Most radiology reports will have a time aspect of “point in time” (PT). A few reports indicate a specific time window (e.g., timed fluoroscopy imaging), and these are named in the usual manner, e.g., <numeric value><S|M|H|W>. Where qualifiers are needed to indicate a relative time frame, we use the following conventions: • • • • Gt = greater than Ge = greater than or equal to Lt = less than Le = less than or equal to For example, Le 1H 4.3.2.3 System For all clinical LOINC terms, the system is spelled out in full and should not be ambiguous. For most radiology reports, the system describes what is being viewed, not only the anatomic area of interest. For example, a common study to identify anterior glenoid pathology is the West Point view x-ray. Because this view demonstrates the entire shoulder, not just the glenoid rim, the system is Shoulder: View West Point:Find:Pt:Shoulder:Doc:XR We name systems that encompass multiple organ systems by joining them with a “plus” (+). The individual parameters are arranged in cephalocaudal and/or proximodistal order: Views:Find:Pt:Spine.cervical+Spine.thoracic+Spine.lumbar:Doc:XR Views:Find:Pt:Spine.lumbar+Sacrum+Coccyx:Doc:XR While the system describes what is being viewed, it is not an exhaustive list of all structures in the view. For example, in practice, a standard lateral view x-ray of the radius and ulna shows these bones in their entirety as well as the proximal row of carpal bones and the elbow joint. Yet, the system for this report would simply be Radius+Ulna. 4.3.2.3.1 Vessels For reports of vascular studies, if the system contains multiple vessels, each vessel is named separately and connected by a plus (+), (e.g., Celiac artery+Superior mesenteric artery+Inferior mesenteric artery). If the vessel(s) being viewed is part of a common root, it is named with the common part first, then a dot (.) separator, and then the division (e.g., Vena cava.inferior). If the vessel(s) are independent branches, then they are named independently and connected by a plus (+), (e.g., Superior mesenteric artery+Inferior mesenteric artery). For studies that view all the vessels in an area, the SYSTEM is typically named in plural form (e.g., Lower extremity vessels, Lower extremity veins). The rationale for this is that most angiography studies demonstrate some vessel branches, not just a single vessel. 71 LOINC® Users’ Guide - June 2016 4.3.2.3.2 Brain, head, cerebral, and skull There is presently much variation in radiology system naming patterns pertaining to the anatomical area of the head. We have modeled our naming patterns largely after prevailing conventions. We generally use a system containing Head for reports of MRA, CTA, CT, and US studies. We use the system of Brain with reports of MRI and nuclear medicine studies, and Skull with plain film study reports. For conventional fluoroscopic angiography reports, we use a system containing Cerebral when not specifying a particular artery. 4.3.2.3.3 Extremities Test names for studies of the extremities often vary in their terminology. The term “arm” technically means the part of the upper limb from shoulder to elbow, but is also commonly used to refer to the entire upper limb, and the term “leg” technically means the part of the lower limb between the knee and ankle, but is also commonly used to refer to the entire lower limb (Dorland’s Illustrated Medical Dictionary30). In lieu of this, we have included “arm” and “leg” as broad synonyms, but do not use them as a system. We use “Upper extremity” and “Lower extremity” to refer to the limbs in their entirety or when the visualized region of the limb is not specified, and we use “Upper arm”, “Forearm”, “Thigh” and “Lower leg” to refer to segments of the upper and lower extremities. For more specific regions, we name the system based on the anatomy visualized with that particular method. For example, we name an x-ray of the upper arm as: Views:Find:Pt:Humerus:Doc:XR 4.3.2.3.4 Laterality For most bilaterally symmetric entities, we create separate LOINC codes for radiology reports differentiated by laterality. Thus, for many studies we have LOINC codes that differ only by the laterality of the system (e.g., Shoulder, Shoulder.left, Shoulder.right, Shoulder.unilateral, and Shoulder.bilateral). 4.3.2.3.5 Series projections with multiple systems For radiology reports on a series of projections that include multiple systems (e.g., Ribs+Chest), the order the projections are listed in the COMPONENT corresponds with the order of the anatomical sites in the system. In addition, the secondary anatomical site is added to the COMPONENT to clarify which views were for which anatomical region. For example: Views lateral & PA chest:Find:Pt:Ribs+Chest:Doc:XR 4.3.2.3.6 Use of dot (.) in system Using a dot (.) in the SYSTEM signifies that the modifier is a subdivision or component of the main word. No dot (.) is used when the modifier is just an adjective used for clarification. So, we have: 30 Dorland’s Illustrated Medical Dictionary. 30th ed. Philadelphia: Saunders/Elsevier; 2003. 72 LOINC® Users’ Guide - June 2016 Chest.pleura, but Superficial tissue. 4.3.2.3.7 Method In general, the method for radiology reports corresponds to the method for other LOINC terms. The pattern for naming a radiology method is: <modality>.[submodality] 4.3.2.3.7.1 Method for angiography terms LOINC terms use the methods of XR.fluor.angio, MRI.angio, and CT.angio to describe angiography study reports. Radiology systems often use the abbreviations MRA, MRV, CTA, and CTV in test names of angiography studies. Because MRA and CTA can refer to studies of arteries, veins, or both, they are equivalent synonyms to the LOINC methods MRI.angio and CT.angio and are included in the database as synonyms. MRV and CTV are added as synonyms only to terms where the method is MRI.angio or CT.angio and the system contains the word “Vein” or “Veins.” Note, for angiography studies performed by Cardiologists, we use the method “Angiography.” 4.3.3 Interventional Radiology Reports 4.3.3.1 Component Radiology reports for interventional studies under imaging guidance typically contain a component of the form: Guidance for <indication>, where <indication> is description of the nature of the guidance. For example: Guidance for biopsy:Find:Pt:Breast:Doc:Mam Guidance for drainage:Find:Pt:Kidney:Doc:US 4.3.3.2 System The system for interventional radiology reports is named for the anatomical structures being viewed, similar to the pattern for systems of diagnostic radiology reports. 4.3.3.3 Method In general, the method for interventional radiology reports corresponds to the method for diagnostic radiology and other LOINC terms. The pattern for naming the method is: <modality>.[submodality] 5 Tumor registry In collaboration with North American Association of Central Cancer Registries, Inc (NAACCR, Inc), we have developed a set of LOINC codes that can be used to communicate tumor registry variables from clinical institutions to tumor registries and among tumor registries. These LOINC terms map to the content of NAACCR data set, and include variables for such things as the hospital at which the tumor was 73 LOINC® Users’ Guide - June 2016 first diagnosed, the primary anatomic site of the tumor, it size, its degree of spread at the time of diagnoses, and a host of other variables of interest to the tumor registries. The NAACCR data set and other cancer-related demographics are identified by the class TUMRRGT. The NAACCR standards and an implementation guide for transmitting these LOINC tumor registry variables within HL7 messages are available from the NAACCR website (http://naaccr.org). 6 Claims attachments For more information see HIPAA Attachments display in RELMA, the HIPAA Attachment section in RELMA Users’ Manual, the respective documents published by HL7 Attachments Working Group, and the Attachments section of the LOINC website (http://loinc.org/attachments). 7 LOINC Document Ontology This section describes our approach to creating a set of document type codes. This work began as a collaboration between the LOINC committee and the HL7 document ontology task force, with initial contributions from Stan Huff, Pavla Frazier, Bob Dolin, Clem McDonald. The background and initial development of the ontology was described by Frazier et al.31 Over time, we have continued to make many refinements to this ontology. In particular, we have received exceptional contributions from colleagues at Columbia University and the U.S. Department of Veterans Affairs. 7.1 Introduction to the use of LOINC document type codes In creating and maintaining document type codes, it is important to distinguish between the purpose of local document names and the names represented by the document type code. Document type codes are created to provide consistent semantics for the names of documents when they are shared or exchanged between independent facilities or enterprises. The names and codes that are used locally within an enterprise are entirely under the control of the local enterprise, and these names are valuable to the workflow and access of information within the enterprise. It is assumed that the exact local name for the document will be retained in the system that created the document, and that the local name can be sent along with the document type code when the document is sent to an external organization. The document type code should only express the meaning in a document name that can be shared between independent organizations. For example, it is appropriate to have local document names like “Dr. Smith’s Tuesday Pain Clinic Note” or “Albuquerque VA General Medicine Consult Note” for use within an enterprise. However, some parts of these very specific local names are not meaningful outside of the originating enterprise Thus, proper document type codes would have names like “Outpatient Pain Clinic Note,” or “General Internal Medicine Consult Note.” Table 22: Example Clinical Notes Possible local terms Document type codes Dr. Smith’s Tuesday Pain Clinic Note Outpatient Pain Clinic Note 31 Frazier P, Rossi-Mori A, Dolin RH, Alschuler L, Huff SM. The creation of an ontology of clinical document names. Stud Health Technol Inform. 2001;84(Pt1):94-8. PubMed PMID: 11604713. 74 LOINC® Users’ Guide - June 2016 Albuquerque VA General Medicine Consult Note General Internal Medicine Consult Note The naming rules in this Document Ontology apply primarily to “clinical notes.” For purpose of this Users’ Guide, a clinical note is a clinical document (as defined by the HL7 CDA Standard), where clinical professionals and trainees produced the document either spontaneously (e.g., I write my admitting note) or in response to a request for consultation. “Clinical Notes” provides a better description of the process. “Clinical Notes” are to be distinguished from patient reports such as radiology reports, pathology reports, laboratory reports, cardiac catheterization reports, etc., that are generated in response to an order for a specific procedure. Names for most of these later concepts are accommodated well by the clinical LOINC naming structure, and many such codes already exist within the LOINC database. We must also emphasize that the names constructed in LOINC are based on the expected information content of the document, rather than the document format. This is to say that the same LOINC code would be used to represent a given document type regardless of whether it was in PDF, text document, JPG, XML, or HTML formats – if the information content contained by those documents were the same. 7.2 Relationship to other standards HL7 HL7 will use LOINC codes for clinical document codes, and will not develop an independent document code system for clinical documents. At its option, HL7 may choose to limit its domain to a subset of LOINC codes. The HL7 document type code domain will overlap with similar concepts found in HL7 V2.x (user defined table 0270 Document Types; user defined table 0496 Consent Types). Our approach to manage this overlap is: • • Create a mapping from LOINC codes to HL7 V2.x document codes. Continue to develop LOINC codes to meet the needs of the HL7 V3 domain that are not present in the V2.x tables. Relationship to a reference terminology As soon as possible, the component terms used in the creation of the names of document type codes will be mapped to either the UMLS Metathesaurus or SNOMED CT. This mapping will help to establish the meaning of the terms and will allow aggregation and classification of document type codes based on definitions, computable relationships, and subsumption hierarchies that exist in the reference terminology. 7.3 Elements of Document Type codes In the following, synonymy or equivalent terms are designated by parenthesis. Document codes are defined by their component parts. The first list of axis values was published in 2003, and served as the basis for an initial set of LOINC codes. Through both empiric analysis and expert review, we have continued evaluating and refining this list. The following listing contains the current set of axis values for the elements of document type codes that have been vetted by the LOINC Committee. We are in the process of carefully harmonizing our existing Document terms with these new values. 75 LOINC® Users’ Guide - June 2016 Kind of Document Description: Characterizes the general structure of the document at a macro level. Document types are differentiated based on the need to define distinct document headers. Allowed Values: Part Number Part Name LP173387-4 LP173388-2 LP173389-0 LP173390-8 LP173391-6 LP173392-4 LP173393-2 LP173394-0 LP173395-7 LP173396-5 LP173397-3 LP173398-1 LP173399-9 LP173400-5 LP173401-3 LP173402-1 LP173403-9 LP193873-9 LP173404-7 LP173405-4 LP173406-2 LP173407-0 LP200113-1 LP173408-8 LP181089-6 LP181085-4 LP173409-6 LP173410-4 LP173411-2 LP173412-0 LP173413-8 LP173414-6 LP173415-3 LP181112-6 LP181116-7 LP181119-1 LP173754-5 LP173755-2 LP173756-0 LP173757-8 LP173758-6 LP173759-4 LP173765-1 LP173766-9 LP173760-2 LP173761-0 LP173762-8 LP173763-6 LP173764-4 LP173118-3 LP173417-9 LP200113-1 LP204161-6 LP181534-1 LP173418-7 LP173419-5 LP173420-3 Administrative note Against medical advice note Agreement Certificate Birth certificate Death certificate Evaluation of mental and physical incapacity certificate Consent Abortion consent Anesthesia consent Hysterectomy consent Organ donation consent Procedure consent Release of information consent Sterilization consent Surgical operation consent Contract Driver license Health insurance card Health insurance-related form Health record cover sheet Legal document Legal letter Power of attorney Request Prescription request Advance directives Do not resuscitate Rescinded do not resuscitate Living will Rescinded advance directive Diagram Flowsheet Form Instructions Action plan ADHD action plan Anaphylaxis action plan Asthma action plan Autism action plan Complex medical conditions action plan Cystic fibrosis action plan Diabetes type I action plan Diabetes type II action plan Heart disease action plan Inflammatory bowel disease action plan Multiple sclerosis action plan Muscular dystrophy action plan Seizure disorder action plan Discharge instructions Letter Legal letter List Prescription list Note Adverse event note Alert 76 LOINC® Users’ Guide - June 2016 LP181207-4 LP181204-1 LP181529-1 LP181530-9 LP181190-2 LP181531-7 LP181532-5 LP181533-3 LP181534-1 LP156982-3 LP173421-1 LP183503-4 LP183502-6 Order Prescription Prescription for diagnostic or specialist care Prescription for durable medical equipment attachment Prescription for eyewear Prescription for medical equipment or product Prescription for medication Prescription for rehabilitation Prescription list Photographic image Report Case report Registry report Further explanation of LOINC’s use of “Note” (i.e. a Clinical Note, also known as “Clinical Document”): Documents generated by clinicians as part of patient care, which includes notes written at the initiative of “individual clinic and consulting clinicians.” It does not include clinical reports such as, radiology, pathology, and cardiac catheter reports that are usually stimulated by a particular order. Clinical documents meet five criteria, as defined in CDA 1.0: wholeness, stewardship, authentication, persistence, and human readability. Type of Service Description: Characterizes the kind of service or activity provided to/for the patient (or other subject of the service) as described in the note. Common subclasses of service would be evaluations, consultations, and summaries. The notion of time sequence, e.g., at the beginning (admission) at the end (discharge) is subsumed in this axis. Allowed Values: Part Number Part Name LP173107-6 LP173099-5 LP173109-2 LP173110-0 LP173111-8 LP173100-1 LP173113-4 LP173112-6 LP173114-2 LP173115-9 LP173116-7 LP173117-5 LP173120-9 LP173121-7 LP173122-5 LP173129-0 LP173130-8 LP173131-6 LP173132-4 LP173133-2 LP173134-0 LP173135-7 LP173136-5 LP173137-3 LP173138-1 LP173139-9 LP173140-7 LP173105-0 LP173141-5 LP173142-3 LP173143-1 LP173144-9 LP173145-6 Communication Conference Case conference Consultation Confirmatory consultation Counseling Group counseling Individual counseling Daily or end of shift signout Diagnostic study Inhalation challenge test Education Discharge teaching Preoperative teaching Evaluation and management Care Crisis intervention (psychosocial crisis intervention) Disease staging Disability examination Social security administration compensation examination Compensation and pension examination VA C&P exam.acromegaly VA C&P exam.aid and attendance &or housebound VA C&P exam.arrhythmias VA C&P exam.miscellaneous arteries &or veins VA C&P exam.audio VA C&P exam.bones VA C&P exam.bones fractures &or bone disease VA C&P exam.brain &or spinal cord VA C&P exam.chronic fatigue syndrome VA C&P exam.cold injury protocol VA C&P exam.cranial nerves VA C&P exam.Cushings syndrome 77 LOINC® Users’ Guide - June 2016 LP173146-4 LP173147-2 LP173148-0 LP173149-8 LP173150-6 LP173151-4 LP173152-2 LP173153-0 LP173168-8 LP173154-8 LP173155-5 LP173156-3 LP173157-1 LP173158-9 LP173159-7 LP173160-5 LP173161-3 LP173162-1 LP173163-9 LP173164-7 LP173165-4 LP173166-2 LP173167-0 LP173169-6 LP173170-4 LP173171-2 LP173172-0 LP173173-8 LP173174-6 LP173175-3 LP173176-1 LP173177-9 LP173178-7 LP173179-5 LP173180-3 LP173181-1 LP173182-9 LP173183-7 LP173184-5 LP173185-2 LP173186-0 LP173187-8 LP173188-6 LP173106-8 LP173189-4 LP173190-2 LP173191-0 LP173124-1 LP173123-3 LP173125-8 LP173204-1 LP173205-8 LP173200-9 LP173126-6 LP173127-4 LP173128-2 LP204157-4 LP173192-8 LP173193-6 LP173194-4 LP173195-1 LP173196-9 LP173197-7 LP175731-1 LP208913-6 LP173198-5 LP173199-3 LP173200-9 LP173202-5 LP173201-7 VA C&P exam.dental &or oral VA C&P exam.diabetes mellitus VA C&P exam.miscellaneous digestive conditions VA C&P exam.ear disease VA C&P exam.mental health eating disorders VA C&P exam.miscellaneous endocrine diseases VA C&P exam.epilepsy &or narcolepsy VA C&P exam.esophagus &or hiatal hernia VA C&P exam.extremity joints VA C&P exam.eye VA C&P exam.feet VA C&P exam.fibromyalgia VA C&P exam.general medical VA C&P exam.genitourinary VA C&P exam.disability in gulf war veterans VA C&P exam.gynecological conditions &or disorders of the breast VA C&P exam.hand &or thumb &or fingers VA C&P exam.heart VA C&P exam.hemic disorders VA C&P exam.HIV-related illness VA C&P exam.hypertension VA C&P exam.infectious &or immune &or nutritional disabilities VA C&P exam.large &or small intestines VA C&P exam.liver &or gall bladder &or pancreas VA C&P exam.lymphatic disorders VA C&P exam.general mental disorders VA C&P exam.mouth &or lips &or tongue VA C&P exam.multiple exam VA C&P exam.muscles VA C&P exam.miscellaneous neurological disorders VA C&P exam.nose &or sinus &or larynx &or pharynx VA C&P exam.peripheral nerves VA C&P exam.initial evaluation post-traumatic stress disorder VA C&P exam.review evaluation post-traumatic stress disorder VA C&P exam.prisoner of war protocol VA C&P exam.pulmonary tuberculosis &or mycobacterial diseases VA C&P exam.rectum &or anus VA C&P exam.residuals of amputations VA C&P exam.miscellaneous respiratory diseases VA C&P exam.obstructive &or restrictive &or interstitial respiratory diseases VA C&P exam.scars VA C&P exam.sense of smell &or taste VA C&P exam.skin diseases other than scars VA C&P exam.social &or industrial survey VA C&P exam.spine VA C&P exam.stomach &or duodenum &or peritoneal adhesions VA C&P exam.thyroid &or parathyroid diseases Evaluation Annual evaluation Functional status assessment Initial evaluation Admission evaluation Admission history and physical Readiness for military duty assessment Risk assessment and screening Fall risk assessment Safety issue assessment Evaluation and management of a specific problem Evaluation and management of anticoagulation Evaluation and management of hyperlipidemia Evaluation and management of hypertension Evaluation and management of overweight and obesity Evaluation and management of smoking cessation Evaluation and management of substance abuse Evaluation and management of workers compensation History and physical Annual history and physical Admission history and physical Labor and delivery admission history and physical Comprehensive history and physical 78 LOINC® Users’ Guide - June 2016 LP173203-3 LP204160-8 LP173206-6 LP173209-0 LP173213-2 LP173211-6 LP173214-0 LP173215-7 LP173216-5 LP173103-5 LP173218-1 LP173221-5 LP173223-1 LP173222-3 LP175732-9 LP173225-6 LP173224-9 LP200117-2 LP173226-4 LP189614-3 LP173227-2 LP173228-0 LP173229-8 LP173230-6 LP204160-8 LP173231-4 LP207306-4 LP173232-2 LP203673-1 LP203034-6 LP203035-3 LP204130-1 LP173233-0 LP173234-8 LP173235-5 LP173236-3 LP173237-1 LP173238-9 LP173240-5 LP173104-3 LP173242-1 Targeted history and physical Medical equipment or product Plan Plan of care Progress Restraint Surgical operation Postoperative evaluation and management Preoperative evaluation and management Summary Antepartum summary Discharge summary Labor and delivery summary Maternal discharge summary Population summary Summary of death Summary of episode Summary of encounters Transfer summary Weight management summary Transplant candidate evaluation Transplant donor evaluation Well child visit Exercise testing Medical equipment or product Medication management Medication administration Medication reconciliation Notification Admission notification Discharge notification Visit notification Outreach Procedure Interventional procedure Pathology procedure Autopsy Referral Respite Supervisory Triage Setting Description: Setting is a modest extension of CMS’s coarse definition of settings, which have well defined meanings. Setting is not equivalent to location, which typically has more locally defined meanings and is reported in other parts of the message. Setting would be limited to one of the following categories (with some future extensions possible). Most clinical report names would include a setting (at least at the top level) to avoid confusion between important classes of reports. For example, The Admission H&P is usually taken to be the Hospital Admission H&P, but it could be confused with the nursing home H&P if not distinguished by the setting. Setting is not a required component of the name. Allowed Values: Part Number Part Name LP173041-7 LP173042-5 LP173043-3 LP173065-6 LP173045-8 LP173046-6 LP173047-4 LP173048-2 Ambulance Birthing center Emergency department Hospital Intensive care unit Long term care facility Custodial care facility Nursing facility 79 LOINC® Users’ Guide - June 2016 LP173049-0 LP173050-8 LP173051-6 LP173052-4 LP173053-2 LP173054-0 LP173055-7 LP173056-5 LP220237-4 LP173057-3 LP173058-1 LP173059-9 Skilled nursing facility Unskilled nursing facility Outpatient Ambulatory surgical center Office Outpatient hospital Urgent care center Patient's home Pharmacy Rehabilitation hospital Telehealth Telephone encounter Subject Matter Domain (SMD) Description: Characterizes the subject matter domain of a note. Allowed Values: Part Number Part Name LP172911-2 LP172915-3 LP172916-1 LP172925-2 LP172918-7 LP172981-5 LP172919-5 LP172923-7 LP172933-6 LP172934-4 LP172935-1 LP172924-5 LP172936-9 LP172987-2 LP172940-1 LP172957-5 LP172988-0 LP173027-6 LP183499-5 LP173035-9 LP172942-7 LP176905-0 LP172943-5 LP172913-8 LP172947-6 LP173027-6 LP172894-0 LP172944-3 LP172946-8 LP172952-6 LP172913-8 LP172921-1 LP172914-6 LP172927-8 LP172953-4 LP172941-9 LP172938-5 LP173032-6 LP172945-0 LP172950-0 LP172947-6 LP175685-9 LP172951-8 LP183500-0 LP175686-7 LP172962-5 Acupuncture Aerospace medicine Allergy and immunology Clinical and laboratory immunology Anesthesiology Pain medicine Audiology Chiropractic medicine Critical care medicine Dentistry Dermatology Clinical and laboratory dermatological immunology Dermatopathology Pediatric dermatology Emergency medicine Medical toxicology Pediatric emergency medicine Sports medicine Trauma Undersea and hyperbaric medicine Ethics Exercise physiology Family medicine Adolescent medicine Geriatric medicine Sports medicine Forensic medicine Forensic psychiatry General medicine Internal medicine Adolescent medicine Cardiovascular disease Advanced heart failure and transplant cardiology Clinical cardiac electrophysiology Interventional cardiology Endocrinology Diabetology Thyroidology Gastroenterology Hepatology Geriatric medicine Hematology Infectious disease HIV Medical oncology Nephrology 80 LOINC® Users’ Guide - June 2016 LP173015-1 LP173023-5 LP173027-6 LP172956-7 LP172926-0 LP172928-6 LP172929-4 LP172930-2 LP172959-1 LP172958-3 LP173011-0 LP172912-0 LP172922-9 LP172944-3 LP172948-4 LP173013-6 LP173012-8 LP172960-9 LP172963-3 LP172964-1 LP172931-0 LP172965-8 LP172898-1 LP172981-5 LP173038-3 LP172968-2 LP172899-9 LP172971-6 LP202989-2 LP172955-9 LP173020-1 LP172973-2 LP172901-3 LP202989-2 LP175686-7 LP172991-4 LP173016-9 LP207940-0 LP172974-0 LP172975-7 LP172902-1 LP172978-1 LP172977-3 LP173029-2 LP172979-9 LP172980-7 LP172967-4 LP172994-8 LP173007-8 LP172982-3 LP172983-1 LP172984-9 LP208907-8 LP172936-9 LP208906-0 LP172920-3 LP208902-9 LP208903-7 LP173002-9 LP172913-8 LP172922-9 LP172937-7 LP172950-0 LP172957-5 LP172961-7 LP192135-4 LP172985-6 LP172986-4 LP172987-2 LP172989-8 Pulmonary disease Rheumatology Sports medicine Medical genetics Clinical biochemical genetics Clinical cytogenetics Clinical genetics Clinical molecular genetics Molecular genetic pathology Mental health Psychiatry Addiction psychiatry Child and adolescent psychiatry Forensic psychiatry Geriatric psychiatry Psychosomatic medicine Psychology Multi-specialty program Neurological surgery Neurology Clinical neurophysiology Neurology neurodevelopmental disabilities Neurology w special qualifications in child neuro Pain medicine Vascular neurology Nuclear medicine Nutrition and dietetics Obstetrics and gynecology Gynecologic oncology Maternal and fetal medicine Reproductive endocrinology Occupational therapy Oncology Gynecologic oncology Medical oncology Pediatric hematology-oncology Radiation oncology Surgical oncology Ophthalmology Optometry Oral and maxillofacial surgery Orthopaedic surgery Orthopedic sports medicine Surgery of the hand Orthotics prosthetics Otolaryngology Neurotology Pediatric otolaryngology Plastic surgery within the head and neck Palliative care Pastoral care Pathology Anatomic pathology Dermatopathology Clinical pathology Blood banking and transfusion medicine Chemical pathology Medical microbiology – pathology Pediatrics Adolescent medicine Child and adolescent psychiatry Developmental-behavioral pediatrics Hepatology Medical toxicology Neonatal perinatal medicine Birth defects Pediatric cardiology Pediatric critical care medicine Pediatric dermatology Pediatric endocrinology 81 LOINC® Users’ Guide - June 2016 LP172988-0 LP172990-6 LP173000-3 LP172991-4 LP172992-2 LP172993-0 LP172994-8 LP172995-5 LP172996-3 LP172997-1 LP172998-9 LP172999-7 LP173027-6 LP173003-7 LP220238-2 LP173004-5 LP172954-2 LP172981-5 LP172997-1 LP173026-8 LP173040-9 LP173005-2 LP173006-0 LP173007-8 LP173029-2 LP173008-6 LP173009-4 LP172957-5 LP172972-4 LP173035-9 LP173010-2 LP173014-4 LP204156-6 LP173018-5 LP172939-3 LP172896-5 LP172969-0 LP172996-3 LP173016-9 LP173017-7 LP173037-5 LP173019-3 LP173021-9 LP173022-7 LP173024-3 LP173025-0 LP173028-4 LP172932-8 LP172999-7 LP173029-2 LP173030-0 LP207940-0 LP173031-8 LP207300-7 LP173033-4 LP183499-5 LP173039-1 LP173034-2 LP173036-7 LP173001-1 LP185997-6 Pediatric emergency medicine Pediatric gastroenterology Pediatric transplant hepatology Pediatric hematology-oncology Pediatric infectious diseases Pediatric nephrology Pediatric otolaryngology Pediatric pulmonology Pediatric radiology Pediatric rehabilitation medicine Pediatric rheumatology Pediatric surgery Sports medicine Pharmacology Clinical pharmacology Physical medicine and rehabilitation Kinesiotherapy Pain medicine Pediatric rehabilitation medicine Spinal cord injury medicine Vocational rehabilitation Physical therapy Plastic surgery Plastic surgery within the head and neck Surgery of the hand Podiatry Preventive medicine Medical toxicology Occupational medicine Undersea and hyperbaric medicine Primary care Public health Community health care Radiology Diagnostic radiology Interventional radiology Nuclear radiology Pediatric radiology Radiation oncology Radiological physics Vascular and interventional radiology Recreational therapy Research Respiratory therapy Social work Speech-language pathology Surgery Colon and rectal surgery Pediatric surgery Surgery of the hand Surgical critical care Surgical oncology Thoracic and cardiac surgery Cardiac surgery Transplant surgery Trauma Vascular surgery Tumor board Urology Pediatric urology Wound care management Role Description: Characterizes the training or professional level of the author or the party responsible for the content in the document. The role category is a high-level classification that does not get as detailed as specialty or subspecialty so as to avoid potential overlap with the subject matter domain axis. 82 LOINC® Users’ Guide - June 2016 Allowed Values: Part Number Part Name LP173066-4 LP173067-2 LP173068-0 LP173069-8 LP173071-4 LP173072-2 LP173073-0 LP203036-1 LP173074-8 LP173075-5 LP173076-3 LP173077-1 LP173078-9 LP173079-7 LP173080-5 LP173081-3 LP173082-1 LP173083-9 LP181523-4 LP173084-7 LP173090-4 LP173085-4 LP173086-2 LP173087-0 LP173088-8 LP173089-6 LP173091-2 LP173092-0 LP173093-8 LP173094-6 LP173095-3 Assistant Case manager Clerk Counselor Hygienist Interdisciplinary Team Rapid response team Medical assistant Nurse CRNA Certified nursing assistant Clinical nurse specialist Nurse midwife Nurse practitioner Licensed practical nurse Registered nurse Patient Pharmacist Physician Physician assistant Physician attending Physician consulting Physician fellow Physician intern Physician resident Student Medical student Nursing student Technician Therapist * Physician subsumes medical physicians and osteopathic physicians. 7.4 Rules for Creating Clinical Notes from Multiple Components Names for required clinical notes would be constructed by picking entries from the Kind of Document axis and at least one of the other four axes (see exceptions below). The LOINC committee will create LOINC codes for all required combinations (not all possible combinations). The original document ontology terms were created only for the document type of “note” and with the general naming pattern: <Subject Matter Domain> : <Training / Professional Level>: <Setting>: <Type> : Note As we have revised and refined the elemental axes in the document ontology, simple names would be constructed and ordered as follows: Table 23. Document Ontology LOINC Naming Rules Component Property Time System Scale Method Class <Type of Service> <Kind of Document> Find Pt <Setting> Doc <SMD>.<Role> DOC.ONTOLOGY 83 LOINC® Users’ Guide - June 2016 In general, combinations from within an axis are allowed in a term name where they make sense (typically SMD and Service), but are disallowed where they do not (typically Role and Setting). Combinations will be represented with a plus (+), so as to distinguish from elements containing “and” or “&”. Where a particular element is not defined for a given term and leaves a LOINC axis blank, the LOINC name will include the {} naming convention. For example, if a Setting is not designated, the System will be “{Setting}”. Where neither the SMD nor Role is specified, {Role} is used in the Method (as of LOINC version 2.54). LOINC codes for clinical notes designed according to this model and are assigned a class of DOC.ONTOLOGY. The class name was changed in LOINC version 2.50 from DOC.CLINRPT to DOC.ONTOLOGY, a more representative name for all types of documents (not just clinical reports) included in the LOINC Document Ontology. Example LOINC codes in the Document Ontology include: Table 24. Example Document Ontology LOINC Codes Component Property Time System Scale Method Class Group counseling note Find Pt Hospital Doc {Role} DOC.ONTOLOGY Note Find Pt Outpatient Doc {Role} DOC.ONTOLOGY Admission evaluation note Find Pt {Setting} Doc General medicine DOC.ONTOLOGY History and physical note Find Pt {Setting} Doc {Role} DOC.ONTOLOGY For every clinical note term we create with a designated Setting, SMD, and/or Role, we will also create a general “roll-up” term where the Setting, SMD and Role are not specified, i.e. they are defined as {Setting} and {Role}. The LOINC Committee has agreed not to create a general document code in some cases, including: 1) The Component contains only one axis value, either a Type of Service or Kind of Document. Such a generic code (absent the other attributes) would violate the current policy to include the Kind of Document plus at least one other axis value. 2) The general type of clinical document is not likely to ever exist Example LOINC codes that do not have a general clinical note term include: Table 25. LOINC Code Exceptions to Creating a General Clinical Document Code Component Property Time System Scale Method Class Anesthesia consent Find Pt {Setting} Doc Patient DOC.ONTOLOGY Organ donation consent Find Pt {Setting} Doc Patient DOC.ONTOLOGY Health insurance card Find Pt Doc Patient DOC.ONTOLOGY Triage+Care note Find Pt Doc Nurse DOC.ONTOLOGY Prescription request Find Pt {Setting} Emergency department Pharmacy Doc Pharmacist DOC.ONTOLOGY 7.4.1 Exceptions to Rules for Creating Clinical Notes As noted above, the current policy for creating clinical notes is to include the Kind of Document plus at least one other axis value. The LOINC Committee has agreed to make exceptions to the Document 84 LOINC® Users’ Guide - June 2016 Ontology rules for cases where only Kind of Document is commonly designated (e.g. Driver license). Example LOINC codes that are approved exceptions containing only a Kind of Document: Table 26. LOINC Codes with only a Kind of Document Component Property Time System Scale Method Class Administrative note Find Pt {Setting} Doc {Role} DOC.ONTOLOGY Asthma action plan Find Pt {Setting} Doc {Role} DOC.ONTOLOGY Birth certificate Find Pt {Setting} Doc {Role} DOC.ONTOLOGY Death certificate Find Pt {Setting} Doc {Role} DOC.ONTOLOGY Case report Find Pt {Setting} Doc {Role} DOC.ONTOLOGY Driver license Find Pt {Setting} Doc {Role} DOC.ONTOLOGY Photographic image Find Pt {Setting} Doc {Role} DOC.ONTOLOGY Prescription list Find Pt {Setting} Doc {Role} DOC.ONTOLOGY The LOINC Committee also recognizes the need for terms with only a general Kind of Document (e.g. Letter, Note, Report) designated. We have agreed to create such terms, however, they will have a status of “discouraged” to caution users. If these general terms are used, we strongly recommend that they are used in a post-coordinated manner in conjunction with one of the LOINC terms included in the LOINC Document Ontology associated observations panel [LOINC: 80582-0] to carry the relevant attribute specifications. 7.5 Document Ontology Content in the LOINC Distribution Beginning with LOINC version 2.44 (June 2013), a delimited text file containing the relationships between clinical document terms (i.e. those within the class of DOC.ONTOLOGY) and their associated ontology axis values is available as a separate download from http://loinc.org. The document ontology axis values have been assigned LOINC Part identifiers and classified according to their document ontology axis. This file defines the relationships between a given LOINC term and its ontology axis values through these fields: LoincNumber, PartNumber, PartTypeName, PartSequenceOrder, PartName. These fields are largely self-explanatory, but of note is that the PartTypeName corresponds to the document ontology axis, and the PartSequenceOrder is relevant for terms that combine axis values from within an axis (see section 7.4). 7.6 Future Work We continue active development and refinement of the Kind of Document axis. As we continue this work, we intend to develop equally specific definitive documents for other kinds of health care associated documents. 7.7 Proposing new LOINC document terms New LOINC document type codes can be proposed using the process described in Appendix D. In general, new term proposals that contain allowed combinations of existing axis values will be made expeditiously by Regenstrief staff. Requests for document titles containing new axis values to be added to the ontology will be reviewed by the LOINC committee, and thus their final modeling may take a bit longer. 8 Panels (Batteries) 85 LOINC® Users’ Guide - June 2016 Beginning with version 1.0o, the LOINC database was expanded to include order sets/panels. We use the word “panel” to mean collector terms that contain links to an enumerated set of discrete child elements. Across domains, this generic concept of a collection might be called a battery, form, data set, etc. The same general panel structure in LOINC is used to represent all of these kinds of collections. 8.1 Goals Our work in creating panels was stimulated by many requests for a standard set of test order codes from medical information system vendors who want to install their systems with a usable starter set of standard codes for common orders. They also want standard codes to ease the cross communications among merging hospitals. LOINC codes have been defined for most individual laboratory observations and for many clinical observations, and claims attachments. The same LOINC codes can be used to order individual laboratory and clinical observations, as well as to report the result. For example, a LOINC code for Blood Hemoglobin (LOINC # 718-7) could be used as easily to order the test as to report its result. In HL7 messages, the field where the code is used indicates its role as an order (e.g. OBR-4) or a result observation (OBX-3). Similarly, pre-existing LOINC codes could also be used to order more complex observations. The LOINC code used to order Urinary Creatinine Clearance (LOINC # 2164-2) actually implies an order for two distinct measures (serum creatinine and 24-hour urine creatinine) that are used to calculate the creatinine clearance. However, the existing single value LOINC codes could not be used to order many laboratory and clinical procedures that are ordered as a single-named test (battery), such as CBC, urine dipsticks, blood differential count, and LDH isoenzymes. Similarly physicians order blood pressure measures and expect to get (at least) the diastolic blood pressure and the systolic blood pressure. Though these are separate observations, for practical purposes one is never measured without the other. Initially, we created LOINC codes for the common “fixed” packages of observations. By fixed, we mean that certain kinds of measures will always be part of the battery, and the production of that particular set of measurements is tightly bound to the procedure, instruments that produce the values, or by a government mandate (e.g., LOINC # 24325-3: Hepatic function HCFA 2000 panel). Over time, we have evolved our approach to building panels of other observation collections. (For information on using the ORDER_OBS field of the LOINC database to help find panels that could be used as orders, see section 10.3.) 8.2 Types of results found in panels To understand the rules about how LOINC creates panels and how to map your local panels to LOINC panels, it is important to distinguish among several kinds of “results”. 8.2.1 Primary measurements or observations These observations report key measured results, and may indicate the presence/absence or amount of a substance or organism in the sample. For example, in an electrolytes panel, measured amounts of sodium, potassium, chloride, and bicarbonate would be the primary measures. 86 LOINC® Users’ Guide - June 2016 8.2.2 Derived observations These observations are derived from mathematical or logical operations on the primary measurements. For example, in an electrolytes panel, the anion gap is a derived measure that is calculated by subtracting the concentrations of chloride and bicarbonate (anions) from the concentrations of sodium and potassium (cations). 8.2.3 Ask at order entry (AOE) questions and other associated observations These observations are obtained from the requester as part of the test order and are generally delivered back to the requester as part of the result package. For example, the concentration of inspired oxygen is always an AOE question for blood gas measurements. Similarly, the date of last menstrual period is an AOE question for pap smears. Other kinds of observations are operationally treated in a similar manner although they may not be “questions” in the literal sense. For example, the volume and times (start, stop, duration) of urine collection are often sent along with the order and back again with the results. We call these “associated observations” and consider them like AOEs for the purpose of this discussion. 8.2.4 Impressions, interpretations, and comments LOINC defines an impression/interpretation as a summary statement about multiple observations. This kind of summary observation is often included in collections of results sent back to the requester. (Such summary observation terms in LOINC have the Property of “Imp”, for impression, in their name). As an aside, we note that decisions about test results being outside of normal range are best reported with the Interpretation Code (commonly referred to as the “Abnormal flag”) field of the HL7 OBX structure and not as a separate interpretation observation. 8.3 LOINC rules for panel names We use most of the same general LOINC naming rules for panels as we do for individual observations. Here we describe some of the key unique features of panel names. 8.3.1 Component If a government authority recognizes the panel or order set, we will name such panels with the year that the recognition took effect. For example, LOINC includes the “Comprehensive metabolic 2000 panel”. For panels consisting of more than three constituent tests, the component name will be a concatenation of: (1) (2) A name (e.g., Hemogram, Differential count, Vital Signs) to convey the content of the panel The word “Panel” included to unambiguously identify that this LOINC term refers to a panel or battery In the case that a well-defined panel exists but has no conventional name or the panel consists of three or less constituents, we will include each of the distinct measured entities separated by ampersand (&) in the Component. We may also use a more efficient syntax that implies a repeat of the first part of the name, e.g., Chlamydia Ab IgM & IgG Panel. In general, LOINC creates different codes for panels that contain reflex testing versus those that do not. 87 LOINC® Users’ Guide - June 2016 Such panels will include “reflex” in the Component name, and the general approach is to name the base panel and the kind of test(s) or test panel done as a reflex in the panel name. The reflex test(s) can be a single test, a group of tests, or a test panel. 8.3.2 Property and Scale Because the Property typically varies across the elements of a panel, the Property (i.e. the second part of the LOINC name) for the panel term may be populated by a dash (-). Likewise, the Scale (5th part of the LOINC name) will be populated by a dash (-) if the panel elements contain different scales. 8.3.3 Time Aspect and System Because these parts of the LOINC name are typically consistent across the primary measures of a panel, the Time Aspect and System of a panel name are usually specified with the same conventions that apply to observation terms. 8.3.4 Examples of LOINC Panel names The following are a few examples of LOINC Panels (Order Set Names): Table 27: Examples of LOINC Panel Names (Order Set Names) LOINC_NUM 24358-4 24359-2 24317-0 LOINC Fully Specified Name Description Hemogram WO platelets panel:-:Pt:Bld:Qn Hemogram WO platelets & W manual differential panel :-:Pt:Bld:Qn Hemogram & platelets WO differential panel::Pt:Bld:Qn HCT & HGB & WBC & RBC & Indices 24338-6 Gas panel:-:Pt:Bld:Qn 24336-0 Gas panel:-:Pt:BldA: Qn 24339-4 Gas panel:-:Pt:BldV:Qn 29274-8 Vital signs measurement:Find:Pt:^Patient^Multi 24357-6 Urinalysis macro (dipstick) panel:-:Pt:Urine:- 29576-6 Bacterial susceptibility panel:-:Pt:Isolate:OrdQn Hemogram & Differential Count HCT & HGB & WBC & RBC & Indices & Platelets pH & PO2 & PCO2 on blood without specifying whether arterial, venous, or other source. The report would usually include an observation about the inspired O2 sent along with the report. It may include a variety of other patient characteristics sent by the requester and a variety of computed variables. pH & PO2 & PCO2 on arterial blood. The report would usually include an observation about the inspired O2 sent along with the report. It may include a variety of other patient characteristics sent by the requester and a variety of computed variables. pH & PO2 & PCO2 on venous blood. The report would usually include an observation about the inspired O2 sent along with the report. It may include a variety of other patient characteristics sent by the requester and a variety of computed variables. Diastolic Blood Pressure & Systolic Blood Pressure & Pulse Rate & Respiratory Rate Urinalysis dipstick results. Usually includes Glucose, Bilirubin, estimate of leukocytes, estimate of RBCs, estimate of bacteria, Ph, Specific gravity. But we do not make distinctions about the exact set of measures on the dipstick. The ordering clinician will not necessarily know what particular dipstick is being used and is not able or interested in making those distinctions. Would include susceptibility results for the antibiotics relevant to the isolates and the kind of culture. 8.4 Representing conditionality Within the LOINC panel structure, we can set an attribute for each element of the panel that denotes whether or not it should be present (conditionality) in the panel when resulted. The primary measures are always required, but the other elements of the panel may have different kinds of conditionality. 88 LOINC® Users’ Guide - June 2016 The conditionality attribute is visible on the details pages for panel terms under the column “R/O/C” and stored in the “ObservationRequiredInPanel” field of the LOINC panels and forms file (available for download from the LOINC website). Through version 2.48 of the LOINC database, the conditionality choices were limited to R (Required), O (Optional) and C (Conditional). Examples of simple order sets with terms that are either R or O: Table 28: Example Order Sets 24358-4 Hemogram WO platelets panel - Pt Bld Qn R/O/C 26464-8 Leukocytes NCnc Pt Bld Qn R 26453-1 Erythrocytes NCnc Pt Bld Qn R 718-7 Hemoglobin MCnc Pt Bld Qn R 20570-8 Hematocrit VFr Pt Bld Qn R 30428-7 Mean corpuscular volume 28539-5 Erythrocyte mean corpuscular hemoglobin 28540-3 30384-2 30385-9 24326-1 EntVol Pt RBC Qn R EntMass Pt RBC Qn R Erythrocyte mean hemoglobin concentration MCnc Pt RBC Qn R Erythrocyte distribution width EntVol Pt RBC Qn O Erythrocyte distribution width Ratio Pt RBC Qn O - Pt Ser/Plas Qn R/O/C Electrolytes 1998 panel 2951-2 Sodium SCnc Pt Ser/Plas Qn R 2823-3 Potassium SCnc Pt Ser/Plas Qn R 2075-0 Chloride SCnc Pt Ser/Plas Qn R 2028-9 Carbon dioxide SCnc Pt Ser/Plas Qn R 330373 Anion gap SCnc Pt Ser/Plas Qn O Starting with version 2.50 (December 2014), we expanded the choices beyond R, O and C to include R-a (Required with alternative), Rflx (Reflex) and Rflx-a (Reflex with alternative). The expanded choices better accommodate reflex tests, cases in which more than one test could be used to fulfill a given requirement of the panel, and focus the use of C (which had previously been used as a “catch-all” for many types). Table 29 describes the expanded set of conditionality choices. Table 29: Options for Term Conditionality within Panels Code Meaning Discussion /Definition R R-a Required Required with alternatives Means this test must be included. Means required but has alternatives. The alternatives will usually be paired, and both will be marked with the R-a code. Results for at least one member of the pair must be included in the panel to satisfy the required condition, but both may be included. The C, conditional, had been used to deal with these cases in the past. The rule for pairing up of the alternatives for a given purpose will be described in narrative usually in the panel description because the same rule will apply to many pairings in the panel. For example, the LA panel includes lots of coagulation measures and almost all can be reported as an actual time and/or as the ratio of patient time to the normal time. Measures of the same clotting function that differ only by how they are reported would be considered paired alternatives in this panel. More specific pairing rules may also be asserted in the “condition for inclusion” field associated with each item in the panel. C Conditional Means that the required status of a given variable is depends on other factors. This was too much of a waste basket category, which is why we added some new categories to specify what had usually been lumped as conditional. O Optional Means the variable may be included or not, but whether it is included or not has no bearing on the whether a given set 89 LOINC® Users’ Guide - June 2016 of result represents the given panel. Simple calculations derived from other reported measurements and ask at order entry questions are almost always optional. Rflx Reflex Means this test will be included in the panel only if it satisfies a reflex condition based on other results in the panel. Such cases had also been lumped under the conditional code in the past. In general, we will not define specific rules for reflexing except in very general terms. Rflx-a Reflex with alternatives Means that that the test is a reflex but that another test in the panel can serve as an alternate and either or both of these reflex tests can be reported. But if the reflex condition is met, at least one of the alternative pairs must be included. As in the case of R-a, what tests pair up as alternative will be defined in narrative in the panel description of the condition for inclusion field. If more than one measure can serve as a primary measurement, then both of them will be required with alternatives (R-a), and the criteria is that at least one of them must be present. An example would be the absolute count of neutrophils versus the percentage of total white count of neutrophils in a differential blood count – if one is absent the other must be present (of course they are both often reported). The criteria or explanation for when the tests with R-a, Rflx and Rflx-a should be included in the results for a particular panel can be seen on the comprehensive details page available within RELMA and the online LOINC search application (search.loinc.org). Note that the conditionality assigned to a term is panel-specific. In other words, a given test may be required in one context and optional in another, which is why both the conditionality and criterion for inclusion only appear in the panel details and not in the individual term details. We should acknowledge that LOINC includes many panels without the required status having been marked and that the conditional status has not been employed everywhere that it could have been, and that many terms marked as conditional under the previous model probably would be better categorized as required with alternatives, reflex, or reflex with alternative. (We still have LOINC development work to do.) 8.4.1 Lupus anticoagulant (LA) testing as an example of complex conditionality Here we describe lupus anticoagulant (LA) testing as a prototype to illustrate the use of conditionality. At the core of lupus anticoagulant (LA) testing is a three step process using a given coagulation measure, such as dRVVT. The first is a screening to determine whether a clotting abnormality exists. The second is a mixing study, in which the patient specimen is mixed with pooled normal plasma (PNP) and the same test (e.g. dRVVT) is rerun. This second test is used to evaluate whether the clotting problem is due to a clotting factor deficiency, such as occurs in Hemophilia. The third is yet another repeat of the same test (e.g. dRVVT) mixed with excess phospholipid – also called the confirmatory test. Lupus anticoagulant is declared present if the addition of excess phospholipid normalizes the result. There are a number of variations in LA testing algorithms across laboratories. Some labs do the confirm test second and the mixing study third (if needed). The International Society of Thrombosis and Haemostasis (ISTH) recommends using two clotting tests: dRVVT and aPTT-LA (lupus sensitive), each reflexing to confirm and/or mixing study. However, at least two labs use three screening tests, adding PT to the dRVVT and aPTT-LA, reflex to mixing and confirm studies from these, and add further reflex testing, including thrombin time and from that a reflex to reptilase time. There are also variations in how the results are reported, e.g. as actual clotting times and/or as ratios of the actual time to the time of normal. And some labs define the kind of phospholipid they use for the confirm study, i.e., hexagonal or platelet derived phospholipid. 90 LOINC® Users’ Guide - June 2016 The LA panel for three screening tests shown below illustrates a number of issues related to conditionality described above. The three screening tests (dRVVT, aPTT and PT) are all required but can either be reported as the actual result or actual/normal, therefore all six terms are assigned the conditionality R-a. The mixing and confirmatory tests as well as thrombin time and reptilase time are only run if any of the screening tests are out of range and when run, can also be report as actual or actual/normal; therefore, all of these terms are assigned Rflx-a. The dRVVT and aPTT percent correction and screen to confirm ratio may not be reported by all laboratories and therefore have an O status. Finally, the overall interpretation must be reported and so is assigned R. Figure 1. Details page for three screening test lupus anticoagulant panel 8.5 Approach to creating and defining distinct panels in LOINC 8.5.1 General approach The defining characteristics of a LOINC panel term include the enumerated set of child elements and the conditionality of those elements. Thus, users must pay close attention to the full panel structure in order to know whether it is an appropriate representation of their local panel. When LOINC defines a panel, it will include all of its primary measurements/observations (flagged as required), and will also include commonly reported derived observations (flagged as optional). When laboratories report an interpretation across many observations in a panel, such as the differential count or a serum electrophoresis, the LOINC panel will include an interpretation term specific to that panel (flagged as optional). Likewise, the panel will also contain commonly included AOE variables and other 91 LOINC® Users’ Guide - June 2016 associated observations (flagged as optional). LOINC will not define distinct panels for different collections that vary only on the optional elements (whether or not there is an interpretation, an additional derived calculation, variables sent along with the request, etc.). As a corollary, users can match their local panels to LOINC panels whether or not their reported results include those optional elements. During the several years prior to the LOINC 2.56 release, the number of requests for panel terms steadily increased. At the same time, newer laboratory methods have led to the creation of lab kits that could be customized by the end-user in terms of the individual tests that were run. For example, if a kit includes ten different assays, one hospital might implement six while another hospital might implement all ten of the assays. In addition, each version of the kit could potentially have different combinations of tests. Many of our requests were for panels that differed only slightly from existing panels, likely in part due to differences in the aforementioned kit implementation. Going forward, it now appears impractical to create a unique panel for every hospital, laboratory, and test kit. Therefore, at the June 2016 meeting, the Laboratory LOINC Committee agreed upon the following business rules for new panel requests: 8.5.1.1 Panels for test kits We will make generic panels for groups of tests that are not specific to a particular manufacturer or test kit but that are method- and system-specific. Such panels will not have conditionality or cardinality specified. As test kits evolve over time, additional children may be added, but none will be removed except in limited circumstances. Examples of such panels are: 79381-0 Gastrointestinal pathogens panel - Stool by Probe and target amplification method 82180-1 Meningitis+Encephalitis pathogens DNA and RNA panel - Cerebral spinal fluid by Target amplification with non-probe based detection Panels for individual laboratories and/or hospitals In general, we will not create new panels for every hospital and laboratory, based on their unique combination of elements. However, we likely will make panels when many hospitals and/or labs use the exact same set of elements. 8.5.1.2 Fully specified panels We will make panels with conditionality and cardinality details in cases where a specific guideline or standard of care exists, such as the lupus anticoagulant screening panel examples above. 8.5.1.3 8.5.2 Preference for methodless panel definitions In most cases, LOINC will not make up different panel terms for the same set of tests done by different methods. Because of the possible mixtures of methods within a panel, representing these distinctions would cause an explosion of the distinct panel, which would (usually) be a burden on the ordering provider. Further, in a given setting the ordering provider can only order the methods that are provided by his usual producer. Implied in the order is “Give me the battery produced by your usual methods”. Thus, as a general approach we tend to create panels with child elements that are methodless. In special circumstances though, we do create panels of method-specific observations. For example, we 92 LOINC® Users’ Guide - June 2016 have different panels for screen and confirm methods. In such cases, the method specification is defining characteristic of the panel. 8.5.3 Special cases where enumeration of child elements is not practical There are special cases where LOINC may define a panel term by a narrative definition because it is not practical to fully enumerate all of the possible child elements and their conditionality. For example, public health, veterinary medicine, and other laboratories that are not charging Medicare or Medicaid for the tests they perform are not bound by the rules that penalize labs for performing and charging for tests that the practitioner did not explicitly order. This makes creating order panels a little easier. In the case of public health, the tests performed by a laboratory in response to a request may be chosen from a list of many possible tests, based on information provided by the requester, and the laboratory’s judgment. For example, CDC’s “Campylobacter, Helicobacter and related organisms identification and subtyping” (CDC-10127) order can include tests that identify the phenotype, the genotype, Penner serotype, PFGE, or AST, and might use multiple test procedures for each of these. 9 Evolving principles for naming collections 9.1 Goals and general approach We are in the process of evolving our model for naming collections in LOINC. Our goals in refining this model are to: • • • • Create names that are consistent across different subject domains within LOINC Make it easy to create a list of all codes that could be used as document type in CDA Make it easy to create a list of all codes that could be used as section headings in CDA Avoid proliferating names To this end, we are developing rules for naming of collections will apply to both laboratory collections (CBC, CHEM7) coded and structured clinical collections (Vital Signs), documents (Admit History and Physical Exam), Apgar scores, Braden Scale, Pain scales, etc. There will be two categories of names for collections: • Names for panels with enumerated discrete contents, and • Names for general collections of information. Using the existing panel mechanisms, the LOINC database will record the association between LOINC collections and individual observations where these associations are known. For example, LOINC already records the expected contents for CBC, Liver Enzymes, etc. It will also include definitions for Vital Signs, Cardiac Catheterization, Braden Scale, surveys, etc. We will create a single LOINC code for any general collection of information where the information content of the collection is the same, regardless of whether the content is a text document, a scanned image of text, or a sound file of the same information. Since collections are named by their real or anticipated contents, the same LOINC code could be used as 93 LOINC® Users’ Guide - June 2016 either a document type or as a section type. 9.2 Collections as orders and observations The same LOINC code will be used for ordering a procedure, naming the document produced as the description of the procedure, or naming the structured and coded set of observations from the procedure. For panels, the same code for CBC would be used as the ordered item in an order record or message, and as the panel identifier in the OBR segment of a result record or message. The same pattern would be followed for laboratory procedures and clinical procedures. For general collections, the same code would be used as the ordered item in an order record or message, and as the result identifier in a result message. For example, the general collection name could be used in a result message as the identifier of a document type, as a section label, as the universal identifier in an OBR segment, or as the identifier in and OBX segment depending on the circumstances. The same pattern would be followed for radiology procedures and clinical procedures. We are not taking away the flexibility of having the ordered code be different from the result code. For example, it is often desirable for the order code to be less specific and more abstract than the result code. LOINC would contain codes for something like “Exercise EKG” with the expectation that the result could come back as “AHA Protocol Stress EKG Result”. The point is that when appropriate we would use the same LOINC code in the contexts of orders and results. We would NOT make LOINC codes that meant “CBC Order” and “CBC Result”, we would use the same LOINC code for CBC in both orders and results. Current practice would also continue where a “pure” procedure is ordered and discreet results would be returned. For example, Urine Microscopic Exam could be ordered and discreet values for cell types, casts, amorphous material, etc. would be returned. 9.3 LOINC SCALE for collections The SCALE for panels will be a dash (-). The Scale for general information collections will be “Doc”, short for document, which is used in the most general sense of a text document, image, scanned text image, etc. “Doc” would replace the current use of Nar (narrative) or Nom (nominal) for general information collections in the current LOINC database. The LOINC committee will review current contents of the LOINC database and modify names appropriately to conform to the new conventions. We will not implement the name changes until after the current Attachments NPRM is final. 9.4 Examples of proposed changes according to new policy Table 30: Example of Proposed Changes LOINC# Component Property Time System Scale Method Class/Type 24358-4 Hemogram panel - Pt Bld - PANEL.HEM/BC 24320-4 Basic Metabolic HCFA 98 panel - Pt Ser/Plas - PANEL.CHEM 24362-6 Renal Function HCFA 2000 Panel - Pt Ser/Plas - PANEL.CHEM 94 LOINC® Users’ Guide - June 2016 34566-0 Vital signs panel - Pt ^Patient 11488-4 Consultation note Find Pt 34066-1 Boxed warning section - - Doc DOC.REF. 35511-5 Background information section - - {Setting} ^FDA package insert ^Clinical trial protocol - Doc DOC.REP.CTP 35660-0 Path report.final diagnosis section – text Imp Pt Specimen Doc TUMRRGT 24534-0 Multisection Find Pt Abdominal vessels Doc Doc PANEL.VITALS {Role} US.doppler ATTACH.CLINRPT RAD 10 Additional Content in the LOINC Distribution 10.1 LOINC Answers and Answer Lists Across many domains, the meaning of a particular observation can be best understood in the context of the set of possible answers (result values). For example, the questions/items in standardized assessment instruments often have highly specialized, fixed answer lists. In many contexts, it is the answer list that most completely defines the meaning of concept represented by the question. Additionally, because many of the answer choices are highly specialized, few are represented by existing codes in reference terminologies. For these reasons, we have created a structured representation of answer lists in LOINC. We identify the binding of LOINC observation codes to answer lists as “normative”, “preferred”, or “example”. Normative lists are those specifically defined by a validated instrument or other authoritative source. When using LOINC codes bound to normative answer lists, only answers in the specified set are allowed as result values. Examples of sources for Normative answer lists are PROMIS or the Clinical Pharmacogenetics Implementation Consortium (CPIC). Preferred lists contain a set of answers that users are strongly encouraged to use. They represent a recommended set, however, in contrast to a Normative list, alternate result values may be used if necessary. Preferred lists may come from a variety of sources, including professional organizations (e.g., American Physical Therapy Association), device manufacturers, and government (e.g., Centers for Diseases Control and Prevention, National Eye Institute). Example lists are meant to be illustrative of possible result values. Users can also think of them as a starter set to which they may add or subtract depending on their use case. Many of the Example answer lists are in the lab domain, where different labs may report similar results in a variety of ways, such as “Positive”, “Present”, “Detected”, “Abnormal” or “Out of range” but for which we have a single Example answer list. Not all answer lists are fully enumerated within LOINC. For example, some questions may have their answers drawn from a large terminology such as ICD-9-CM or CPT and we do not reproduce those lists within the LOINC structure. Answer lists that are not fully enumerated within LOINC are flagged to indicate that they are externally defined. We record the answer list OID (whether assigned by Regenstrief or another organization) and optionally a URL pointing to an external system. Individual answers are assigned a non-semantic identifier with a “LA” prefix and a mod-10 check digit (see Appendix C). The answer codes LOINC assigns are unique by lexical string (ignoring capitalization), and by intention do not distinguish between strings that may have different meanings depending on their contextual use. LOINC answer lists are available for viewing in the RELMA program, and are also contained in the LOINC panels and forms file that is part of the LOINC distribution. 95 LOINC® Users’ Guide - June 2016 10.1.1 Null flavors in LOINC answer lists It is often necessary to indicate that a valid result value is not present. For example, on question on a questionnaire might have set of response choices and then one choice at the end like “unknown”, “not applicable”, “not available”, etc. In HL7 standards, these kinds of response values are called null flavors (see http://hl7-fhir.github.io/v3/NullFlavor/index.html). There are two techniques for communicating a null flavor. In version 3 messaging, there is a dedicated nullFlavor attribute that is available for every observation, so these choices are not part of the actual answer list. In version 2 messaging and FHIR, the convention includes the specific allowed null flavors within the choices of the answer set. We can see advantages to both approaches. Within LOINC, we do not want to make different answer lists that vary only by the inclusion or exclusion of certain null flavors. This is true even for normative answer lists. Thus, our policy is to add specific null flavors as entries in the answer list where we are aware of their relevance. But, any LOINC answer list (including normative lists) can be extended or limited by null flavors without violating the intended conformance that is specified through the binding. So, if a normative answer list included an “unknown” answer choice, LOINC would not create a separate code for the same observation with “not available” in the answer list instead of “unknown”. From the perspective of conformance to the LOINC meaning, users are also free to make such substitutions, insertions, or exclusions of null flavor(s) in the answer list. 10.2 LOINC Parts and Part Hierarchies In order to support several key aspects of development, Regenstrief has created LOINC Parts, which are a coded representation of a value for a dimension used to specify a LOINC Term. LOINC Parts support the translation of LOINC terms into other languages, easy linking of synonyms across many terms, the creation of hierarchies to group related LOINC terms, and several other functions. Individual LOINC Parts are assigned a non-semantic identifier with a “LP” prefix and a mod-10 check digit. The intended use of the LOINC parts and LOINC part hierarchies are to organize or be constituents of LOINC terms. As described in the LOINC license, they are not intended for use as a “standalone” terminology nor apart from LOINC terms. Furthermore, LOINC parts and LOINC part hierarchies are not strictly managed under the same policies (e.g. concept orientation, concept permanence) as are LOINC terms. 10.3 Use of the ORDER_OBS field for LOINC terms LOINC terms can be matched to local test codes that fulfill different roles. For example, a LOINC code can be used to place an order, to report discrete observations, or in some cases a LOINC term can serve in both ways. The purpose of the ORDER_OBS field in the LOINC database is to provide users with an idea of the intended use of the term by categorizing it as an order only, observation only, or both. A fourth category, Subset, is used for terms that are subsets of a panel but do not represent a collection of items that is known to be orderable. Our categorization of a term in this way is not a normative or binding resolution. That is, it is not a definitional attribute of the term. Rather, it represents Regenstrief’s best approximation 96 LOINC® Users’ Guide - June 2016 of how the term is used. (If you feel a term should be categorized a different way, please let us know). In HL7 messages, the place in the message where the LOINC code is used will indicate what role the LOINC term is fulfilling. If it is in OBX-3, it is being used as an observation. If it is in OBR-4, it is an order. Example of Order Only: LOINC 34531-4, Blood Type & Crossmatch Panel, is an order for a type and cross, but you would never expect it to carry an answer (i.e. result value). Panel terms typically fall in the Order only category. Example of Observation Only: LOINC 51890-2, Factor VIII Units given, is a LOINC code that is a discrete observation that would carry a result of the number of units given to the patient, but a clinician would never place an order for ‘Factor VIII Units given’. Example of Both: LOINC 882-1, ABO & Rh Group in Blood, is a LOINC term that could be used to place an order as well as report the result of the test (e.g. A Positive). 11 Standardized Assessment Measures 11.1 Introduction The LOINC committee approved inclusion of standardized assessment measures (e.g., survey instruments) with version 1.0p. Representing the observations in these assessments within LOINC required a modest extension of the System axis to include aggregate units of analysis, such as “family”, and storage of additional attributes within the LOINC database. Bakken32 provides a detailed description of the methodology for inclusion and evaluation into LOINC and the extensions to the LOINC axes. The initial corpus of material represented in LOINC came from standardized nursing assessment instruments, including: Home Health Care Classification (HHC), Quality Audit Marker (QAM), Signs and Symptoms Checklist for Persons with HIV (HIV-SSC), Living with HIV, and the Omaha System. We have since expanded the content to cover standardized assessment instruments in many other domains. As we have added content, we have iteratively refined our modeling. Vreeman et al have published a summary of our approach and its evolution.33 32 Bakken S, et al. Evaluation of Clinical LOINC (Logical Identifiers, Names, and Codes) for Terminology Model for Standardized Assessment of Measures. JAMIA 7:2000; 529-538. 33 Vreeman DJ, McDonald CJ, Huff SM. LOINC® - A Universal Catalog of Individual Clinical Observations and Uniform Representation of Enumerated Collections. Int J Funct Inform Personal Med. 2010;3(4):273-291. Epub 2011 May 23. PubMed PMID: 22899966. 97 LOINC® Users’ Guide - June 2016 11.2 Consolidated Health Informatics endorsement As national interest in using standards for communicating the results of patient assessment instruments has increased, we have collaborated with members of the Consolidated Health Informatics (CHI) Disability Workgroup and many others to more fully develop the content and infrastructure to support patient assessment instruments. LOINC now contains full representations of CMS’s Minimum Data Set version 2 (MDS) used in nursing homes, CMS’s Outcome and Assessment Information Set (OASIS) used in home health care, and the Social Security Administration’s Residual Functional Capacity (RFC) instrument. Our work with CHI Disability Workgroup has led to the endorsement of Clinical LOINC as a CHI standard for federally-required assessment (i) questions and answers, and (ii) assessment form that include functioning and disability content. The recommendations of the CHI Disability Workgroup were endorsed by the NCVHS and subsequently the HHS Secretary. 11.3 LOINC Representation The overall organization of the survey instruments and other collections are represented in LOINC using a nested panel structure consistent with the existing model for laboratory panels. LOINC codes are created for the individual questions/items within an instrument, as well as for the panels/groups of terms representing the hierarchical nature of the instrument. We recognize that standardized assessments have psychometric properties that are essential to their interpretation, and so the data model includes elements such as the actual question text and allow answer options as attributes of the LOINC observation code. 11.3.1 Naming rules and conventions for names of collection terms (e.g. a panel, survey instrument) LOINC creates codes for the collection as described in the section on Order Panels (batteries). Typically, the Property and Scale attributes are a hyphen “-“, because the child elements (questions) vary in these axes. We create different panel terms for different versions of the same instrument where there are meaningful changes (e.g. different questions asked, different answer choices, etc). Some assessment instruments of the same version have different “forms” for various purposes that contain unique collections of items. For example, the OASIS-C has five unique forms that represent different subsets of questions that are used at various times: Start of Care, Resumption of Care, Follow-up, Transfer to a Facility, and Discharge from Agency. LOINC creates different panel terms for each of these forms. 11.3.2 Attributes of the LOINC terms for individual questions or variables The LOINC table contains fields that store additional attributes relevant to many terms for individual questions or variables. Examples include the fields that store the exact question text, external copyright notice, example units, and the HL7 field where the content should be delivered (if Null, presume OBX). In order to accommodate inclusion of instruments that are copyrighted by a third party, we have added an External Copyright field to the LOINC table. This field stores the specified terms of use, and additionally, these terms are visually highlighted in the RELMA program when they appear in search results. We have only included content in this manner that is consistent with LOINC’s overall aim, so the content allows free use and distribution for clinical, administrative, and research purposes either with permission or under applicable terms of use. LOINC does not usually create terms for information that has a designated field in an HL7 message. But, in order to create complete sets of items for some instruments we have created LOINC terms for items such as patient first name. To identify this content, we added an HL7 Field Sub ID to the LOINC table and indicate the corresponding HL7 place (e.g. PID-5.2). 98 LOINC® Users’ Guide - June 2016 11.3.3 Structured answer lists The questions/items in standardized assessment instruments often have highly specialized, fixed answer lists. As described above in Section 10.1, we have created a structured representation of the answer lists for the questions in assessment instruments represented in LOINC. 11.3.4 Attributes of items that vary depending on the parent collection Some important attributes of a LOINC term for a question or variable may vary when that concept is used in different assessments or on different forms of the same assessment. For example, “measured body weight” is a variable of many different assessments. In the context of each instrument, that same concept could have different local codes, help text, validation rules, or associated branching logic. We therefore store these attributes at the level of the instance of the item in a particular panel. 11.3.5 Choosing the “display text” for a question or variable As discussed in the previous sections, we have three fields that can capture the exact display of the question/item on the form in question. (For some instruments, it can be difficult to determine what exactly is the question text). The Component of a LOINC term represents the thing or attribute being measured, and is the default for capturing the item text. However, there are several reasons why the component may not be the exact item text. The most important ones include: our LOINC naming conventions do not permit certain characters (e.g. "/" or "?") because of our internal "Part" parsing rules, that some aspects of the question are modeled in other parts of the formal LOINC name, or that there is some important aspect to the "thing being measured" (e.g. a look back period of the last 7 days) that is not represented explicitly on the form for that particular item. In general, for purposes of displaying the item text as it appears on the instrument, one can follow this rule: 1. DISPLAY_NAME_FOR_FORM in the FORM_DATA table (RELMA) or FORMS table (CSV file export) [if populated]. This field provides an override display that is linked to the instance of the LOINC question code in a particular form. It allows for the same clinical concept to have slight presentation variances on different forms where those variances have no change in the concept meaning and accommodates instances where the LOINC naming conventions require some difference between the item and the LOINC Component. For example, an item might have the form label of "Body Mass Index (BMI)" but the LOINC Component would simply be "Body mass index". If the question or variable is from a survey: 2. SURVEY_QUEST_TEXT in the LOINC table [if populated]. This field is populated when the variable/item is asked as a question. In some cases, the variable has both a question and a label. In these cases, the SURVEY_QUEST_TEXT field is populated with both, in the pattern of [Label].[Question text]. For example, for item J0300 on the MDS version 3 we have "Pain Presence. Ask resident: ‘Have you had pain or hurting at any time in the last 7 days?’" 3. COMPONENT in the LOINC table. This is the default display. Else: 4. SHORTNAME in the LOINC table. This field contains a short display name (target is 40 characters or less). 99 LOINC® Users’ Guide - June 2016 5. COMPONENT in the LOINC table. This is the default display. In addition to these fields, some LOINC codes used in survey instruments may have other LOINC name fields such as a Long Common Name and Consumer Name. These additional names may be useful in some contexts for these items, be we will still use the above rule to capture the item's representation in the instrument. Some of the original survey instruments modeled in LOINC may not follow this rule exactly, in part due to the fact that we did not have the full survey representation model as we do presently. Ongoing work includes reviewing where modifications may be needed. 11.3.6 Type of Method (6th part) for a question or variable For variables linked to a defined answer list that come from an external source, it has become our policy to enter the initial source as the Method. For example, variables first entered for the Minimum Data Set (MDS) will have a method of MDS. This does not mean that the term cannot be used in any other contexts, such as other panels or surveys. Many variables from MDS, for example, were later used in the CARE instrument. These variables in the CARE panel still have a method of MDS. As long as the defining context of use is understood, the variable can be used in other contexts where the term is exactly the same, including the answer lists, as the original term. 11.3.7 Time aspect (3rd part) for a question or variable Beginning with the June 2015 LOINC release, the Time aspect for survey questions that include a lookback period specify that look back period as the Time rather than using “Pt”. This change was approved by the LOINC Clinical Committee at the February 2015 Clinical LOINC meeting and will apply to all new terms moving forward. At the August 2015 Clinical LOINC meeting, further naming conventions were approved. These conventions include: • Using the exact timing given in a validated survey question as the Time value (i.e., for questions with a 7 day lookback period, using “7D” for Time rather than “1W”) • Adding “Lifetime” as a possible Time value • For questions with a lookback range, using the longer end of the range for Time (e.g., if the question asks “In the last 2-6 months…”, the Time value will be “6Mo”). As of LOINC version 2.54, nearly all of the existing survey instrument terms that include a look back period have an updated Time part, and we will continue to make these changes moving forward for any terms that were not updated for the 2.54 release. 11.4 Assessment Content in the LOINC Distribution All of the assessment content is included within RELMA. Beginning with LOINC version 2.26 (January 2009), an export of panels and forms content has been available as a separate download in the LOINC release available from http://loinc.org. This spreadsheet contains separate worksheets for the three files defining the full assessment content: 1. The hierarchical structure (parent/child relationships) and panel-specific attributes 2. An extract of the main LOINC Table for all of the terms in the set 3. The structured answer list for each LOINC variable term in the set The full set of all of the panels and forms content, as well as several domain-specific subsets, are 100 LOINC® Users’ Guide - June 2016 available for download from the LOINC website. 12 Editorial Policies and Procedures 12.1 Concept orientation and LOINC name changes LOINC is a concept-based terminology, which means that it provides a way of naming classes of things that exist in the real world. Each concept (term) is given an identifier and a fully-specified name. Other attributes, including other names such as a Short Name and Long Common Name, are also provided in the LOINC database. The concept is anchored by the LOINC code, not by the particular strings in the formal name we happen to use to explain the code. It is certainly not possible to convey all of the subtleties that exist in the world with formal machinery alone, which is why we are also working very hard to include narrative text descriptions with each term that further elaborate and explain the concept. In a complex, organic terminology like LOINC, name changes and modifications are unavoidable for many reasons. Since its inception, LOINC has maintained a set of editorial policies that guide our adherence to this concept-oriented ideal even as the terminology evolves over time. An over-arching policy is that we can change the name (i.e. the human-readable representation of the concept) in any way that does not change the meaning of the concept. In other words, a modification is allowable and valid if it is still an unambiguous reference to a class of things in the real world. For example, two different numbering systems have been used to identify the serotypes of Streptococcus pneumoniae, which are important in gauging the coverage of polyvalent pneumonia vaccines. The U.S. system uses only numbers while the Danish system includes numbers and letters. For a period of time, LOINC term names were split and used a mixture of the Danish and U.S. identifiers, which was inconsistent and confusing. To clarify, we converted the few Danish serotype identifiers to their corresponding U.S. serotype identifiers (and included the Danish identifiers as synonyms). This was not a fundamental change to the underlying concept, but rather just the particular labels used to express it. Not all situations are crystal clear, so our general policy is to seek as much input as is feasible, and typically such cases are brought for discussion to the LOINC Committee. 12.2 Classification of LOINC term status LOINC development follows best practices for terminology system development by never reusing or deleting codes. If a LOINC term is identified as erroneous or a duplicate of a previous term it is flagged as “deprecated” in the database, but the record is not removed. Changes in concept status are made very judiciously. Prior to the LOINC version 2.31 release (June 2010), we identified such deprecated terms by populating the STATUS field of the database with “DEL” and wherever possible identified superseding concepts in the MAP_TO field of the LOINC Table. Active (non-deprecated) records had no value (null) in the STATUS field. Based on new use cases and input from the LOINC community, LOINC 2.31 implemented an expansion to that classification. The presently supported values for term status, with the definition and implications for use, are: ACTIVE TRIAL DISCOURAGED Concept is active. Use at will. Concept is experimental in nature. Use with caution as the concept and associated attributes may change. Concept is not recommended for current use. New mappings to this 101 LOINC® Users’ Guide - June 2016 DEPRECATED concept are discouraged; although existing mappings may continue to be valid in context. Wherever possible, the superseding concept is indicated in the MAP_TO field of the MAP_TO Table (see Appendix A, Table 31b) and should be used instead. Concept is deprecated. Concept should not be used, but it is retained in LOINC for historical purposes. Wherever possible, the superseding concept is indicated in the MAP_TO field of the MAP_TO Table (see Appendix A, Table 31b) and should be used both for new mappings and updating existing implementations. Furthermore, LOINC 2.31 added two new fields: STATUS_REASON STATUS_TEXT Classification of the reason for concept status. This field will be Null for ACTIVE concepts, and optionally populated for terms in other statuses where the reason is clear. DEPRECATED or DISCOURAGED terms may take values of: AMBIGUOUS, DUPLICATE, or ERRONEOUS. Explanation of concept status in narrative text. This field will be Null for ACTIVE concepts, and optionally populated for terms in other statuses. Our initial implementation of these new concept status values populated the STATUS field with “ACTIVE” or “DEPRECATED” based on their existing status and have identified a limited set of terms that have been designated “DISCOURAGED” or “TRIAL”. The principal reason identifying terms as DISCOURAGED is where we have strong inclinations that a particular term is no longer valid given current practice. For example, we have flagged as DISCOURAGED several lutropin terms with Properties consistent with mass or molar units because all lutropin sources that we could reach report concentrations in international units (IU) per volume and the drug lutropin is prescribed in terms of international units per volume. To avoid help confusion on the part of mappers, the DISCOURAGED status steers them away from these terms to the more likely candidates. The principal reason for identifying terms as TRIAL is a very constrained circumstance, such as when the source of the term is still equivocating. This has been illustrated in our work to create a LOINC representation of federally-required patient assessment instruments. Here, the item meaning is defined in the context of use within that instrument. We have been fortunate to work with assessment developers in the early stages of instrument development. This is advantageous because it enables the codes to be included in data specifications and documents as they are developed, but we are in the position of creating codes and names for data elements whose attributes are still in flux. As the instrument evolves, the specific representation of the item (question) or answer options on the form may change. Ultimately, the representation will be settled by an authoritative body (such as CMS) and they are intended for use in one context – the official release of the instrument. Identifying these terms as TRIAL allows us to include them in the public distribution while clearly flagging their “pending” status. Once the final concept representation has been determined, terms initially labeled TRIAL would be reclassified as ACTIVE (or perhaps in rare circumstances DEPRECATED or even rarer DISCOURAGED). In LOINC 2.42, the MAP_TO field of the LOINC Table was removed and replaced with a separate MAP_TO table. The original MAP_TO field was created to store a single replacement LOINC term number for when a LOINC was deprecated. We later learned that there were times when there was more than one possible replacement term, depending on certain conditions. To address this problem we created a new MAP_TO table that was first released with version 2.34. The original MAP_TO field was retained for a few releases, but was removed from the LOINC Table in version 2.42. See Appendix A, Table 31b for information about the MAP_TO table. 102 LOINC® Users’ Guide - June 2016 12.3 Concept persistence and term deprecation LOINC codes are never reused or deleted, and the concept meaning is persistent over time despite the fact that there may be modifications to the name (as described above). If we discover that a LOINC term’s meaning is a duplicate of another existing term or it is somehow erroneous, it will be given a status of DEPRECATED but not removed from the database. In the past, when we encountered duplicate terms (i.e. terms that had different names but meant the same thing), our general policy was to deprecate the newest term. Many times, this convention worked well because the older term was more likely to have been incorporated into user’s systems through mappings, etc. However, this was not always the case. Sometimes, the new term had the clearer, more recognizable label and thus it was most likely the most mapped-to term. Therefore, our current policy is to make the change to require (in our estimation) the least amount of remapping for existing users. 13 Recommendations for Best Practices in Using and Mapping to LOINC 13.1 Business rules for users mapping their local panels to LOINC panels Through discussion with the ACLA, the S&I Framework aLOINC Order Code Initiative, and others, the LOINC Committee has vetted a set of business rules to help LOINC users understand how to compare their panels to a LOINC panel. These rules help clarify what variation is allowed within the LOINC panel definition that still constitutes a “match” for their panel. In these rules, we use “element” to mean a child LOINC that is a member of the panel definition. 13.1.1 Must contain all of the required elements To establish equivalence (e.g. for mapping), a user panel must contain all of the required elements of a LOINC panel. Some of the other business rules define allowable substitutions, but the general rule is that all required elements must be present in the user panel. 13.1.2 No extra primary measurements A user panel cannot be considered equivalent to a LOINC panel term if it contains additional primary measured tests that are not part of the LOINC panel definition. 13.1.3 Optional elements are optional A user panel can be considered equivalent to a LOINC panel term whether or not it contains the elements marked as optional in the LOINC panel definition. 13.1.4 Substitutions related to Method Panel elements that do not contain a Method specification (i.e. the Type of Method part is null) can be treated as a “representative” term that a user could replace with another LOINC term that differed only by specification of method. 103 LOINC® Users’ Guide - June 2016 For example, LOINC contains an adenovirus panel (LOINC # 55160-6 Adenovirus IgG and IgM panel Serum) with two elements that lack method specification: 13914-7 5042-7 Adenovirus IgG Ab [Units/volume] in Serum Adenovirus IgM Ab [Units/volume] in Serum If a user had a local panel that was similar but had instead mapped to terms that specified the method of EIA, they may wonder whether their panel was equivalent to the panel in LOINC. Using this business rule, the answer is yes. Either or both of the methodless LOINC panel elements could be replaced by these method-specific LOINC terms that are equivalent on the other attributes: 51822-5 51823-3 Adenovirus IgG Ab [Units/volume] in Serum by Immunoassay Adenovirus IgM Ab [Units/volume] in Serum by Immunoassay However, when a panel element measures an analyte by a particular method, then the LOINC term reported for that analyte would have to be done by that method. Neither replacement by a methodless term nor by a different method would be allowed. 13.1.5 Substitutions for mass versus substance Properties LOINC defines different terms that distinguish between mass-based and substance-based (moles/milliequivalents) measures for a single analyte. Different jurisdictions vary in whether they favor reporting in mass units (e.g. mg/dL) or molar units (e.g. mmol/L) for certain analytes. In order to promote the international reuse of panels, the LOINC Committee has agreed (at its June 2015 meeting) to allow users to substitute panel elements that a) agree on all other LOINC parts, and b) contain an analogous molar Property to a reference element with a mass Property or vice versa. To illustrate, panel element terms with the property of mass concentration (MCnc) could be replaced by substance concentration (SCnc) terms, mass rate (MRat) terms could be replaced by substance rate (SRat), terms etc. For example, in the Lipid panel with direct LDL - Serum or Plasma (LOINC # 576983) a user could make substitutions as below and still have a comparable panel: Reference term: 2093-3 Substitute term: 14647-2 Cholesterol [Mass/volume] in Serum or Plasma Cholesterol [Moles/volume] in Serum or Plasma Reference term: 2571-8 Substitute term: 14927-8 Triglyceride [Mass/volume] in Serum or Plasma Triglyceride [Moles/volume] in Serum or Plasma And so forth. 13.1.6 No substitutions of quantitative for qualitative (and vice versa) A quantitative panel element (e.g. one that has a Scale of Qn) cannot be replaced by a qualitative term (e.g. one that has a scale of Ord) and have the panel be considered equivalent. Likewise, qualitative terms cannot be replaced by quantitative terms in the panel definition. 13.1.7 Pay attention to reflex components LOINC defines different panels for testing that has reflex elements from ones that do not. Thus, users 104 LOINC® Users’ Guide - June 2016 must be aware of the test(s) done as a reflex both in their local panels and in the LOINC definition. The reflex test(s) can be a single test, a group of tests, or a test panel. A user panel is comparable to the LOINC panel if the specification of reflex testing is the same. 13.1.8 Special case of differential counts (including conventions for not reporting zero counts) Panels, like blood differential counts and urinalyses, for which zero counts (e.g. for the % of blast cells) are usually not reported explicitly present a special case. These are included in the panel definition but are marked as conditional (C) to signal that under some circumstances (e.g., when they have a value of zero), they are not reported. Differential counts present another problem in that a given cell type could be reported as a fraction of the total WBC and/or as an absolute count, so both species are included in the panel for differential counts, but as discussed above, both are not required in the report. 13.1.9 Panels with only narrative definitions of the elements they should contain As described above, in certain special cases such as public health and veterinary testing, LOINC may define a panel term by a narrative definition rather than enumerating the set of child elements. In such cases, the user must read the definition and use their professional judgment as to whether or not their local panel is comparable to the LOINC panel. 13.2 Examples of applying the business rules for users mapping their local panels to LOINC panels 13.2.1 Comparison Panel: Varicella zoster virus IgG and IgM panel - Serum (LOINC # 45063-5) This user-defined panel is considered comparable since the component tests are the same and it is acceptable to use method- specific LOINC codes for panels defined with methodless LOINC codes. Elements of LOINC Panel LOINC_NUM Long Common Name R/O/C 8048-1 Varicella zoster virus IgM Ab [Units/volume] in Serum R 8047-3 Varicella zoster virus IgG Ab [Units/volume] in Serum R Elements of User-defined Panel LOINC_NUM Long Common Name 5404-9 Varicella zoster virus IgM Ab [Units/volume] in Serum by Immunoassay 5403-1 Varicella zoster virus IgG Ab [Units/volume] in Serum by Immunoassay 13.2.2 Comparison Panel: Creatine kinase panel - Serum or Plasma (LOINC # 24335-2) This user-defined panel is not considered to be comparable since it includes 2 additional measured components that are not in the LOINC Panel. NOTE: The inclusion of an Optional component in the LOINC Panel does not have a bearing on the comparability of the user-defined panel. 105 LOINC® Users’ Guide - June 2016 Elements of LOINC Panel LOINC_NUM Long Common Name R/O/C 2157-6 Creatine kinase [Enzymatic activity/volume] in Serum or Plasma R 20569-0 Creatine kinase.MB/Creatine kinase.total in Serum or Plasma R 9642-0 Creatine kinase.BB/Creatine kinase.total in Serum or Plasma R 9643-8 Creatine kinase.MM/Creatine kinase.total in Serum or Plasma R 5912-1 Creatine kinase isoenzymes [interpretation] in Serum or Plasma O Elements of User-defined Panel LOINC_NUM Long Common Name 2157-6 Creatine kinase [Enzymatic activity/volume] in Serum or Plasma 20569-0 Creatine kinase.MB/Creatine kinase.total in Serum or Plasma 9642-0 Creatine kinase.BB/Creatine kinase.total in Serum or Plasma 9643-8 Creatine kinase.MM/Creatine kinase.total in Serum or Plasma 26020-8 Creatine Kinase.macromolecular type 2/Creatine kinase.total in Serum or Plasma 26019-0 Creatine Kinase.macromolecular type 1/Creatine kinase.total in Serum or Plasma 13.2.3 Comparison Panel: Drugs of abuse 5 panel - Urine by Screen method (LOINC # 65750-2) This user-defined panel is considered to be comparable since the components use the same methodspecific LOINC terms and the additional test is a non-measured component (i.e. it is a variable provided by the requester that is echoed back with the results). Elements of LOINC Panel LOINC_NUM Long Common Name R/O/C 19261-7 Amphetamines [Presence] in Urine by Screen method R 14314-9 Benzoylecgonine [Presence] in Urine by Screen method R 18282-4 Cannabinoids [Presence] in Urine by Screen method R 19295-5 Opiates [Presence] in Urine by Screen method R 19659-2 Phencyclidine [Presence] in Urine by Screen method R Elements of User-defined Panel LOINC_NUM Long Common Name 19261-7 Amphetamines [Presence] in Urine by Screen method 14314-9 Benzoylecgonine [Presence] in Urine by Screen method 18282-4 Cannabinoids [Presence] in Urine by Screen method 19295-5 Opiates [Presence] in Urine by Screen method 19659-2 Phencyclidine [Presence] in Urine by Screen method 41395-5 Collection date of Urine 106 LOINC® Users’ Guide - June 2016 13.3 Querying LOINC and creating intensional value set definitions based on LOINC database structure Specifications that contain queries meant to be run on the LOINC distribution or that contain intensional value set definitions should be expressed with the LOINC properties contained in Appendix A - LOINC Database Structure. The available LOINC properties are the items listed in the ‘Field Name’ column of that table. These names, and their spellings, are the official property names. For example, specifying the set of LOINC terms with a scale of document would reference the LOINC property “SCALE_TYP” and its value of “DOC”. In addition, for those LOINC codes that are part of the Document Ontology, there are currently five additional properties that may be used in property-based Value Set Definition components: • • • • • Document.Kind Document.TypeOfService Document.Setting Document.Role Document.SubjectMatterDomain These Document Ontology properties are currently published in the auxiliary Document Ontology File (available as a separate download from the LOINC website), and will likely be extended in the future. They will always be the unique values in the PartTypeName column of the Document Ontology File. All properties will have string values that may be used for the property value part of the definition. 13.4 LOINC term names in HL7 messages Messaging standards like HL7 typically use a triplet <identifier code>^<descriptive text>^<coding system> for fields that contain coded entries, such as the OBX-3 Observation Identifier field. Given that LOINC now produces at least 3 names for each term (i.e., the six-part Fully-Specified Name, Short Name, and Long Common Name), users have wondered which LOINC name they should use in the <descriptive text> part of that field (or the equivalent displayName attribute in HL7 V3). In general, we recommend the use of the Long Common Name because they are probably the most understandable to human readers. However, the Long Common Names can be quite long and some systems may not be able to accommodate them. In these cases, we would recommend the use of the Short Name because they would fit within the space allocated by most reporting systems, could potentially work as a column name on a flow sheet, and mostly use common acronyms. Using the Fully-Specified Name (e.g. a colonseparated aggregate of the six part name) is generally not recommended because they are not as human friendly and contain more instances of ‘reserved characters’ like “^” and “&”, which would need to be properly escaped in the message. Furthermore, we recommend the simultaneous communication of the sender’s local code and local name (in addition to the LOINC code and name) as allowed in the messaging structure to facilitate debugging and detection of mis-mappings. 13.5 Updating to new versions of LOINC At the December 2015 Lab LOINC Committee meeting. Regenstrief and the LOINC Committee approved the following best practice: 107 LOINC® Users’ Guide - June 2016 We recommend that users update to the current version of LOINC within 90 days of its publication. 13.6 Using a URI to identify LOINC concepts as resources in RDF The subject of an RDF statement is a uniform resource identifier (URI), or a blank node. Some users have asked for an approved convention for referring to LOINC concepts in RDF. After discussion at the Clinical LOINC Committee meeting in August 2015, we agreed to the following patterns: For LOINC terms: http://loinc.org/rdf/{LOINC code} e.g. http://loinc.org/rdf/2352-3 For LOINC parts: http://loinc.org/rdf/{LOINC Part code} e.g. http://loinc.org/rdf/LP6990-8 In our current platform, URLs of these patterns resolve to the concept details pages (as used by search.loinc.org and RELMA). 108 LOINC® Users’ Guide - June 2016 Appendix A - LOINC Database Structure Table 31a: LOINC Table Structure Field Name Type Width 1. LOINC_NUM Text 10 2. COMPONENT Text 255 3. PROPERTY Text 30 4. TIME_ASPCT Text 15 5. SYSTEM Text 100 6. SCALE_TYP Text 30 7. METHOD_TYP Text 50 8. CLASS Text 20 Description The unique LOINC Code is a string in the format of nnnnnnnn-n. First major axis-component or analyte Second major axis-property observed (e.g., mass vs. substance) Third major axis-timing of the measurement (e.g., point in time vs 24 hours) Fourth major axis-type of specimen or system (e.g., serum vs urine) Fifth major axis-scale of measurement (e.g., qualitative vs. quantitative) Sixth major axis-method of measurement An arbitrary classification of the terms for grouping related observations together. The current classifications are listed in Table 32. We present the database sorted by the class field within class type (see field 23). Users of the database should feel free to re-sort the database in any way they find useful, and/or to add their own classifying fields to the database. The content of the laboratory test subclasses should be obvious from the subclass name. 9. VersionLastChanged Text 10 10. CHNG_TYPE Text 3 Memo - 12. STATUS Text 11 13. CONSUMER_NAME Text 255 11. DefinitionDescription 109 The LOINC version number in which the record has last changed. For new records, this field contains the same value as the loinc.FirstPublishedRelease field. Change Type Code DEL = delete (deprecate) ADD = add NAM = change to Analyte/Component (field #2); MAJ = change to name field other than #2 (#3 - #7); MIN = change to field other than name UND = undelete Narrative text that describes the LOINC term taken as a whole (i.e., taking all of the parts of the term together) or relays information specific to the term, such as the context in which the term was requested or its clinical utility. ACTIVE = Concept is active. Use at will. TRIAL = Concept is experimental in nature. Use with caution as the concept and associated attributes may change. DISCOURAGED = Concept is not recommended for current use. New mappings to this concept are discouraged; although existing may mappings may continue to be valid in context. Wherever possible, the superseding concept is indicated in the MAP_TO field in the MAP_TO table (see Table 31b) and should be used instead. DEPRECATED = Concept is deprecated. Concept should not be used, but it is retained in LOINC for historical purposes. Wherever possible, the superseding concept is indicated in the MAP_TO field (see Table 31b) and should be used both for new mappings and updating existing implementations. An experimental (beta) consumer friendly name for this item. The intent is to provide a test name that health care consumers will recognize; it will be similar to the names that might appear on a lab report and is not guaranteed to be unique because some elements of the LOINC name are likely to be omitted. We will continue to modify these names in future release, so do not expect it to be stable (or perfect). Feedback is welcome. LOINC® Users’ Guide - June 2016 14. CLASSTYPE Number - 15. FORMULA Text 255 16. SPECIES Text 20 17. EXMPL_ANSWERS Memo - 18. SURVEY_QUEST_TEXT Memo - 19. SURVEY_QUEST_SRC Text 50 20. UNITSREQUIRED Text 1 21. SUBMITTED_UNITS Text 30 22. RELATEDNAMES2 Memo - 23. SHORTNAME Text 40 24. ORDER_OBS Text 15 25. CDISC_COMMON_TESTS Text 1 26. HL7_FIELD_SUBFIELD_ID Text 50 Memo - 28. EXAMPLE_UNITS Text 255 29. LONG_COMMON_NAME Text 255 Memo - Text 255 27. EXTERNAL_COPYRIGHT_NOTICE 30. UnitsAndRange 31. DOCUMENT_SECTION 110 1=Laboratory class; 2=Clinical class; 3=Claims attachments; 4=Surveys Contains the formula in human readable form, for calculating the value of any measure that is based on an algebraic or other formula except those for which the component expresses the formula. So Sodium/creatinine does not need a formula, but Free T3 index does. Codes detailing which non-human species the term applies to. If blank, “human” is assumed. For some tests and measurements, we have supplied examples of valid answers, such as “1:64”, “negative @ 1:16”, or “55”. Verbatim question from the survey instrument Exact name of the survey instrument and the item/question number Y/N field that indicates that units are required when this LOINC is included as an OBX segment in a HIPAA attachment Units as received from person who requested this LOINC term. This field was introduced in version 2.05. It contains synonyms for each of the parts of the fully specified LOINC name (component, property, time, system, scale, method). It replaces #8, Relat_NMS. Introduced in version 2.07, this field contains the short form of the LOINC name and is created via a table driven algorithmic process. The short name often includes abbreviations and acronyms. Defines term as order only, observation only, or both. A fourth category, Subset, is used for terms that are subsets of a panel but do not represent a package that is known to be orderable. We have defined them only to make it easier to maintain panels or other sets within the LOINC construct. This field reflects our best approximation of the terms intended use; it is not to be considered normative or a binding resolution. “Y” in this field means that the term is a part of subset of terms used by CDISC in clinical trials. A value in this field means that the content should be delivered in the named field/subfield of the HL7 message. When NULL, the data for this data element should be sent in an OBX segment with this LOINC code stored in OBX-3 and with the value in the OBX-5. External copyright holders copyright notice for this LOINC code. This field is populated with a combination of submitters units and units that people have sent us. Its purpose is to show users representative, but not necessarily recommended, units in which data could be sent for this term. This field contains the LOINC name in a more readable format than the fully specified name. The long common names have been created via a table driven algorithmic process. Most abbreviations and acronyms that are used in the LOINC database have been fully spelled out in English. Units of measure (expressed using UCUM units) and normal ranges for physical quantities and survey scores. Intended as tailorable starter sets for applications that use LOINC forms as a way to capture data. Units are separated from normal ranges by a colon (:) and sets of unit:normal range pairs are separated by a semi-colon (;). Syntax for the normal range includes square brackets, which mean that the number adjacent to the bracket is included, and parentheses, which means that the number itself is not included. For example, [2,4] means “two to four”, while [2,4) means “two to less than four” and (2,4) means “between two and four but does not include two and four”. Classification of whether this LOINC code can be used a full document, a section of a document, or both. This field was created in the context of HL7 CDA messaging, and populated in collaboration with the HL7 Structured Documents Work LOINC® Users’ Guide - June 2016 Group. 32. EXAMPLE_UCUM_UNITS Text 255 33. EXAMPLE_SI_UCUM_UNITS Text 255 34. STATUS_REASON Text 9 35. STATUS_TEXT Memo - 36. CHANGE_REASON_PUBLIC Memo - 37. COMMON_TEST_RANK Number - 38. COMMON_ORDER_RANK Number - 39. COMMON_SI_TEST_RANK Number - 40. HL7_ATTACHMENT_STRUCTURE Text 15 41. EXTERNAL_COPYRIGHT_LINK Text 255 42. PanelType Text 255 43. AskAtOrderEntry Text 255 44. AssociatedObservations Text 50 111 The Unified Code for Units of Measure (UCUM) is a code system intended to include all units of measures being contemporarily used in international science, engineering, and business. (www.unitsofmeasure.org ) This field contains example units of measures for this term expressed as UCUM units. The Unified Code for Units of Measure (UCUM) is a code system intended to include all units of measures being contemporarily used in international science, engineering, and business. (www.unitsofmeasure.org) This field contains example units of measures for this term expressed as SI UCUM units. Classification of the reason for concept status. This field will be Null for ACTIVE concepts, and optionally populated for terms in other status where the reason is clear. DEPRECATED or DISCOURAGED terms may take values of: AMBIGUOUS, DUPLICATE, or ERRONEOUS. Explanation of concept status in narrative text. This field will be Null for ACTIVE concepts, and optionally populated for terms in other status. Detailed explanation about special changes to the term over time. Ranking of approximately 2000 common tests performed by laboratories in USA. Ranking of approximately 300 common orders performed by laboratories in USA. Corresponding SI terms for 2000 common tests performed by laboratories in USA This field will be populated in collaboration with the HL7 Attachments Work Group as described in the HL7 Attachment Specification: Supplement to Consolidated CDA Templated Guide. Text will either be STRUCTURED or UNSTRUCTURED for relevant terms. The STRUCTURED terms are the allowed document type codes in the Consolidated CDA (C-CDA) Implementation guide. UNSTRUCTURED terms are approved by the HL7 Attachments WG for transmission using the Unstructured Document template of the C-CDA. For terms that have a third party copyright, this field is populated with the COPYRIGHT_ID from the Source Organization table (see Table 31c below). It links a external copyright statement to a term. Describes a panel as a "Convenience group", "Organizer", or "Panel". A "Panel" is an enumerated set of terms that are used together in direct clinical care. The package would typically be thought of as a single orderable item that contains a set of reported observations. A "Convenience group" is an enumerated set of terms used for a common purpose, but not typically orderable as a single unit. An "Organizer" is a subpanel (i.e. a child) within another panel that is only used to group together a set of terms, but is not an independently used entity. They often represent a header in a form, or serve as a navigation concept. A multivalued field, semicolon delimited list of LOINC codes that represent optional Ask at Order Entry (AOE) observations for a clinical observation or laboratory test. A LOINC term in this field may represent a single AOE observation or a panel containing several AOE observations. A multi-valued, semicolon delimited list of LOINC codes that represent optional associated observation(s) for a clinical observation or laboratory test. A LOINC term in this field may represent a single associated observation or panel containing several associated observations. LOINC® Users’ Guide - June 2016 Table 31b: MAP_TO Table Structure Field Name Type Width 1. LOINC Text 10 2. MAP_TO Text 10 Memo - 3. COMMENT Description The deprecated term to which the replacement term(s) apply. A replacement term that is to be used in place of the deprecated or discouraged term. Narrative text that explains the rational for using the recommended replacement term. Table 31c: Source Organization Table Structure Field Name Type Width 1. COPYRIGHT_ID Text 255 Used in the LOINC table as a foreign key. 2. NAME Text 255 3. COPYRIGHT Memo - 4. TERMS_OF_USE Memo - Name of the organization or institution. Copyright notice to be displayed for the organization or institution. Terms of use text for an external source. Text 255 5. URL 112 Description URL link to the reference. LOINC® Users’ Guide - June 2016 Appendix B - Classes Table 32a: Clinical Term Classes Abbreviation Clinical Term Class ADMIN Administrative ADMIN.DEMOG Demographic observations APTA American Physical Therapy Association ART Antiretroviral therapy BDYCRC.ATOM Body circumference atomic BDYCRC.MOLEC Body circumference molecular BDYHGT.ATOM Body height atomic BDYHGT.MOLEC Body height molecular BDYSURF.ATOM Body surface atomic BDYTMP.ATOM Body temperature atomic BDYTMP.MOLEC Body temperature molecular BDYTMP.TIMED.MOLEC Body temperature timed molecular BDYWGT.ATOM Body weight atomic BDYWGT.MOLEC Body weight molecular BP.ATOM Blood pressure atomic BP.CENT.MOLEC Blood pressure central molecular BP.MOLEC Blood pressure molecular BP.PSTN.MOLEC Blood pressure positional molecular BP.TIMED.MOLEC Blood pressure timed molecular BP.VENOUS.MOLEC Blood pressure venous molecular CARD.PROC Cardiac procedures CARD.RISK Cardiac Risk Scales Framingham CARD.US Cardiac ultrasound (was US.ECHO) CARD.US.DICOM DICOM Simplified Adult Echo Report concepts CARDIO-PULM Cardiopulmonary CLIN Clinical NEC (not elsewhere classified) DENTAL Dental DEVICES Medical devices DOC.ADMIN Administrative documents DOC.ADMIN.LEGAL Legal Administrative documents DOC.EPSOS Smart Open Services for European Patients (epSOS) documents DOC.MISC Miscellaneous documentation DOC.ONTOLOGY Document Ontology DOC.PUBLICHEALTH Public health documentation DOC.QUALITY Quality documents DOC.REF Referral documentation DOC.REF.CTP Clinical trial protocol document DOCUMENT.REGULATORY Regulatory documentation ED Emergency (DEEDS) EKG.ATOM Electrocardiogram atomic EKG.IMP Electrocardiogram impression EKG.MEAS Electrocardiogram measures ENDO.GI Gastrointestinal endoscopy EYE Eye 113 LOINC® Users’ Guide - June 2016 EYE.ANGIO.NEI NEI eyeGENE’s angiography concepts EYE.CONTACT_LENS Ophthalmology contact lens EYE.EOG.NEI NEI eyeGENE’s electrooculogram concepts EYE.ERG.NEI NEI eyeGENE’s electroretinogram concepts EYE.GLASSES Ophthalmology glasses: Lens manufacturer (LM) & Prescription EYE.HETEROPHORIA Ophthalmology heterophoria EYE.HX.NEI NEI eyeGENE’s eye history concepts EYE.OCT Ophthalmology Optical Coherence Tomography (OCT) EYE.OCT.NEI NEI eyeGENE’s optical coherence tomography concepts EYE.PX Ophthalmology physical findings EYE.PX.NEI NEI eyeGENE’s eye physical exam concepts EYE.REFRACTION Ophthalmology refraction EYE.REFRACTION.NEI NEI eyeGENE’s refraction concepts EYE.RETINAL_RX Ophthalmology treatments EYE.SLITLAMP.NEI NEI eyeGENE’s slit lamp biomicroscopy concepts EYE.TONOMETRY Ophthalmology tonometry EYE.TONOMETRY.NEI NEI eyeGENE’s tonometry concepts EYE.US Ophthalmology ultrasound EYE.VISUAL_FIELD Ophthalmology visual field EYE.VISUAL_FIELD.NEI NEI eyeGENE’s visual field concepts FUNCTION Functional status (e.g., Glasgow) GEN.US General ultrasound H&P.HX History H&P.PX Physical H&P.SURG PROC Surgical procedure HEMODYN.ATOM Hemodynamics anatomic HEMODYN.MOLEC Hemodynamics molecular HL7.CCDA HL7 Consolidated Clinical Document Architecture HRTRATE.ATOM Heart rate atomic HRTRATE.MOLEC Heart rate molecular HRTRATE.PSTN.MOLEC Heart rate positional molecular HRTRATE.TIMED.MOL Heart rate timed molecular IO.TUBE Input/Output of tube IO_IN.ATOM Input/Output atomic IO_IN.INFUS Infusion pump intake measures IO_IN.MOLEC Input/Output molecular IO_IN.SUMMARY Input/Output summary IO_IN.TIMED.MOLEC Input/Output timed molecular IO_IN_SALTS+CALS Input/Output electrolytes and calories IO_OUT.ATOM Input/Output atomic IO_OUT.MOLEC Input/Output molecular IO_OUT.TIMED.MOLE Input/Output timed molecular NEMSIS National EMS Information System data NEONAT Neonatology variables NEURO Neurology NUTRITION&DIETETICS Nutrition and Dietetics OB.US Obstetric ultrasound OBGYN Obstetric/Gynecology ONCOLOGY Oncology 114 LOINC® Users’ Guide - June 2016 PANEL.APTA American Physical Therapy Association panel PANEL.ART Antiretroviral therapy order set PANEL.BDYTMP Body temperature order set PANEL.BP Blood pressure order set PANEL.CARDIAC Cardiac studies order set PANEL.CLIN Clinical NEC (not elsewhere classified) set PANEL.CV Cardiovascular order set PANEL.DEVICES Medical devices order set PANEL.DOC Documents panels PANEL.ED Emergency (DEEDS) order set PANEL.EYE Ophthalmology panels PANEL.FUNCTION Function order set PANEL.H&P History & Physical order set PANEL.HL7.CCDA HL7 Consolidated Clinical Document Architecture set PANEL.IEEE ROSETTA IEEE Rosetta panels PANEL.IO Input/Output order set PANEL.NEMSIS National EMS Information System data set PANEL.NEONAT Neonatal measures order set PANEL.NUTRITION&DIET Nutrition and dietetics panel PANEL.OB.US Obstetrical order set PANEL.ONCO Oncology set PANEL.PATIENT SAFETY Patient safety order set PANEL.PHENX PhenX Panel PANEL.PHR Public health record order set PANEL.PULM Pulmonary order set PANEL.RAD Radiology order set PANEL.SURG Surgery panel PANEL.TUMRRGT Tumor registry order set PANEL.US.URO Urology ultrasound order set PANEL.VACCIN Vaccination order set PANEL.VITALS Vital signs order set PATIENT SAFETY Patient safety PHENX PhenX PUBLICHEALTH Public Health PULM Pulmonary ventilator management RAD Radiology RESP.ATOM Respiratory atomic RESP.MOLEC Respiratory molecular RESP.TIMED.MOLEC Respiratory timed molecular SKNFLD.MOLEC Skinfold measurements molecular SURG Surgery TRAUMASKNFLD.MOLEC Trauma Skinfold measurements molecular TRNSPLNT.ORGANTRAUMA Organ transplant Trauma TUMRRGTTRNSPLNT.ORGAN Tumor registry (NAACCR)Organ transplant US.UROTUMRRGT Urological ultrasound Tumor registry (NAACCR) VACCINUS.URO Vaccinations Urological ultrasound VOLUME.MOLECVACCIN Volume (specimen) molecular Vaccinations VOLUME.MOLEC Volume (specimen) molecular TRAUMA Trauma 115 LOINC® Users’ Guide - June 2016 TRNSPLNT.ORGAN Organ transplant TUMRRGT Tumor registry (NAACCR) US.URO Urological ultrasound VACCIN Vaccinations VOLUME.MOLEC Volume (specimen) molecular Table 32b: Laboratory Term Classes Abbreviation Laboratory Term Class ABXBACT Antibiotic susceptibilities ALLERGY Response to antigens BLDBK Blood bank CARDIO-PULM Cardiopulmonary CELLMARK Cell surface models CHAL Challenge tests CHAL.ROUTINE Routine challenge tests CHALSKIN Skin challenge tests CHEM Chemistry CHEM.ESOTERIC Esoteric chemistry tests COAG Coagulation study CYTO Cytology DRUG/TOX Drug levels & Toxicology DRUGDOSE Drug dose (for transmitting doses for pharmacokinetics) FERT Fertility HEM/BC Hematology (coagulation) differential count H&P.HX.LAB History for laboratory studies HL7.CYTOGEN Clinical cytogenetic report HL7.GENETICS Clinical genetic report HLA HLA tissue typing antigens and antibodies HNA Human neutrophil alloantigens HPA HPA typing LABORDERS Laboratory order codes MICRO Microbiology MISC Miscellaneous MOLPATH Molecular pathology MOLPATH.DELDUP Gene deletions or duplications MOLPATH.INV Gene inversion MOLPATH.MISC Gene miscellaneous MOLPATH.MUT Gene mutation MOLPATH.NUCREPEAT Nucleotide repeats MOLPATH.PHARMG Pharmacogenomics MOLPATH.REARRANGE Gene rearrangement MOLPATH.TRISOMY Gene chromosome trisomy MOLPATH.TRNLOC Gene translocation NR STATS Normal range statistics PANEL.ABXBACT Susceptibility order sets 116 LOINC® Users’ Guide - June 2016 PANEL.ALLERGY Allergy order set PANEL.BLDBK Blood bank order set PANEL.CELLMARK Cell marker order sets PANEL.CHAL Challenge order set PANEL.CHEM Chemistry order set PANEL.COAG Coagulation order set PANEL.DRUG/TOX Drug level & Toxicology order set PANEL.FERT Fertility testing order set PANEL.HEDIS Healthcare Effectiveness Data and Information Set order set PANEL.HEM/BC Hematology & blood count order set PANEL.HL7.CYTOGEN HL7 cytogenetics panel PANEL.HL7.GENETICS HL7 genetics panel PANEL.HLA HLA order set PANEL.HNA HNA order set PANEL.HPA HPA order set PANEL.MICRO Microbiology order set PANEL.MISC Miscellaneous order set PANEL.MOLPATH Molecular pathology order set PANEL.OBS Obstetrics order set PANEL.PATH Pathology order set PANEL.SERO Serology order set PANEL.SPEC Specimen set PANEL.UA Urinalysis order set PATH Pathology PATH.PROTOCOLS.BRST Pathology protocols - breast PATH.PROTOCOLS.GENER Pathology protocols - general PATH.PROTOCOLS.PROST Pathology protocols - prostate PATH.PROTOCOLS.SKIN SPEC Pathology protocols - skin Serology (antibodies and most antigens except blood bank and infectious agents) Specimen characteristics UA Urinalysis SERO Table 32c: Attachment Term Classes Abbreviation Attachment Term Class ATTACH Attachment ATTACH.AMB Ambulance attachment ATTACH.CARD Cardiac attachment ATTACH.CLINRPT Clinical report attachment ATTACH.CPHS Children's Preventative Health System attachment ATTACH.ED Emergency department attachment ATTACH.GENERAL General attachment ATTACH.GI Gastrointestinal attachment ATTACH.LAB Laboratory attachment ATTACH.MEDS Medication attachment 117 LOINC® Users’ Guide - June 2016 ATTACH.MODIFIER Modifier attachment ATTACH.OBS Obstetrics attachment ATTACH.PERIODONTAL Periodontal attachment ATTACH.REHAB Rehabilitation attachment ATTACH.REHAB.ABUSE Alcohol/Substance abuse rehabilitation attachment ATTACH.REHAB.CARDIAC Cardiac rehabilitation attachment ATTACH.REHAB.NURS Specialized nursing attachment ATTACH.REHAB.OT Occupational therapy attachment ATTACH.REHAB.PSYCH Psychiatric rehabilitation attachment ATTACH.REHAB.PT Physical rehabilitation attachment ATTACH.REHAB.PULM Pulmonary rehabilitation attachment ATTACH.REHAB.RT Respiratory rehabilitation attachment ATTACH.REHAB.SOCIAL Medical social work attachment ATTACH.REHAB.SPEECH Speech therapy rehabilitation attachment ATTACH.RESP Respiratory attachment PANEL.ATTACH.MOD Modifier attachment panel Table 32d: Survey Term Classes Abbreviation Survey Term Class PANEL.SURVEY.AAOS American Academy of Orthopaedic Surgeons PANEL.SURVEY.ADVAULT ADVault survey set PANEL.SURVEY.AHRQ Agency for Healthcare Research and Quality (AHRQ) survey set PANEL.SURVEY.AMNART American National Adult Reading Test (AmNART) set PANEL.SURVEY.AUASI American Urological Association (AUA) Symptom Index set PANEL.SURVEY.BIMS Brief Interview for Mental Health Status (BIMS) set PANEL.SURVEY.BPI Brief Pain Inventory (BPI) set PANEL.SURVEY.CAM Confusion Assessment Method (CAM) set PANEL.SURVEY.CARE Continuity Assessment Record and Evaluation (CARE) set PANEL.SURVEY.CDC Centers for Disease Control (CDC) set PANEL.SURVEY.CMS Centers for Medicare & Medicaid Services set PANEL.SURVEY.COOP Dartmouth Cooperative Functional Status Test (COOP) set PANEL.SURVEY.EPDS Edinburgh Postnatal Depression Scale set PANEL.SURVEY.ESRD End Stage Renal Disease (ESRD) facility survey set PANEL.SURVEY.GDS Geriatric Depression Scale (GDS) set PANEL.SURVEY.GNHLTH General Healthy survey set PANEL.SURVEY.GPCOG General Practitioner Assessment of Cognition (GPCOG) set PANEL.SURVEY.HAQ Health Assessment Questionnaire (HAQ) set PANEL.SURVEY.HARK Humiliation, Afraid, Rape, and Kick (HARK) set PANEL.SURVEY.HHCC Home Health Care Classification set PANEL.SURVEY.HHS Department of Health and Humsn Services set PANEL.SURVEY.HIV-SSC Signs and Symptoms checklist for persons living with HIV set PANEL.SURVEY.howRU howRU outcomes instrument set PANEL.SURVEY.LIV-HIV PANEL.SURVEY.MDS Living with HIV set Minimum Data Set for Nursing Home Resident Assessment and Care Screening set PANEL.SURVEY.MFS Morse Fall Scale set 118 LOINC® Users’ Guide - June 2016 PANEL.SURVEY.MTLHLTH Mental Health survey set PANEL.SURVEY.NEUR Neurological survey set PANEL.SURVEY.NEUROQ Quality of Life Outcomes in Neurological Disorders (NeuroQol) set PANEL.SURVEY.NHANES National Health and Nutrition Examination Survey (NHANES) set PANEL.SURVEY.NHCS National Health Care Survey (NHCS) set PANEL.SURVEY.NMMDS Nursing Management Minimum Data set PANEL.SURVEY.NORTON Norton Scale survey set PANEL.SURVEY.NSRAS Neonatal Skin Risk Assessment Scale survey PANEL.SURVEY.OASIS Outcome and Assessment Information Survey set PANEL.SURVEY.OMAHA PANEL.SURVEY.OPTIMAL OMAHA survey set Outpatient Physical Therapy Improvement in Movement a Assessment Log set PANEL.SURVEY.PAS Patient Activity Scale (PAS) set PANEL.SURVEY.PASII Patient Activity Scale II (PAS-II) set PANEL.SURVEY.PCORI PANEL.SURVEY.PCORNET Patient-Centered Outcomes Research Institute (PCORI) set Patient Centered Outcomes Research Network (PCORnet) Common Data Model (CDM) set PANEL.SURVEY.PHQ Patient Health Questionnaire set PANEL.SURVEY.PROMIS Patient Reported Outcomes Measurement System set PANEL.SURVEY.QAM Quality Audit Marker set PANEL.SURVEY.QRDA Quality Health Reporting Document Architecture set PANEL.SURVEY.RFC Residual Functional Capacity set PANEL.SURVEY.SAMHSA Substance Abuse and Mental Health Services Administration (SAMHSA) set PANEL.SURVEY.USSGFHT United States Surgeon General Family Health Tool (USSGFHT) set PANEL.TIMP Test of Infant Motor Performance (TIMP) set PANEL.UPDRS Unified Parkinson's Disease Rating Scale (UPDRS) SURVEY.AAOS American Academy of Orthopaedic Surgeons (AAOS) survey SURVEY.ADHD Attention Deficit Hyperactivity Disorder (ADHD) SURVEY.ADVAULT ADVault survey SURVEY.AHRQ Agency for Healthcare Research and Quality (AHRQ) survey SURVEY.AMNART American National Adult Reading Test (AmNART) SURVEY.AUASI American Urological Association (AUA) Symptom Index SURVEY.BPI Brief Pain Inventory (BPI) SURVEY.CARE Continuity Assessment Record and Evaluation (CARE) survey SURVEY.CDC Centers for Disease Control (CDC) survey SURVEY.CERNER Cerner survey SURVEY.CMS Centers for Medicare & Medicaid Services (CMS) survey SURVEY.COOP Dartmouth Cooperative Functional Status Test (COOP) SURVEY.EPDS Edinburgh Postnatal Depression Scale (EPDS) SURVEY.ESRD End Stage Renal Disease (ESRD) facility survey SURVEY.GDS Geriatric Depression Scale (GDS) survey SURVEY.GNHLTH General Health survey SURVEY.GOSE Glasgow Outcome Scale Extended (GOS-E) SURVEY.GPCOG General Practitioner Assessment of Cognition (GPCOG) SURVEY.HAQ Health Assessment Questionnaire (HAQ) SURVEY.HARK Humiliation, Afraid, Rape, and Kick (HARK) SURVEY.HHS Department of Health and Human Services (HHS) survey SURVEY.howRU howRU outcomes instrument survey SURVEY.HWS Healthy Weight Summary (HWS) 119 LOINC® Users’ Guide - June 2016 SURVEY.MDS Minimum Data Set (MDS) for Nursing Home Resident Assessment and Care Screening survey SURVEY.MFS Morse Fall Scale (MFS) survey SURVEY.MISC Miscellaneous survey SURVEY.MTLHLTH Mental Health survey SURVEY.NHANES National Health and Nutrition Examination Survey (NHANES) SURVEY.NEURO Neurological survey SURVEY.NEUROQ Quality of Life Outcomes in Neurological Disorders (NeuroQol) survey SURVEY.NHCS National Health Care Survey (NHCS) SURVEY.NIH_TOOLBOX NIH Toolbox survey SURVEY.NMMDS Nursing Management Minimum Data Survey (NMMDS) SURVEY.NORTON Norton Scale survey SURVEY.NSRAS Neonatal Skin Risk Assessment Scale (NSRAS) SURVEY.NURSE.HHCC Home Health Care Classification (HHCC) survey SURVEY.NURSE.HIV-SSC Signs and Symptoms Checklist (SSC) for persons living with HIV survey SURVEY.NURSE.LIV-HIV Living with HIV survey SURVEY.NURSE.OMAHA OMAHA survey SURVEY.NURSE.QAM Quality Audit Marker (QAM) survey SURVEY.OASIS SURVEY.OPTIMAL Outcome and Assessment Information Survey (OASIS) Outpatient Physical Therapy Improvement in Movement and Assessment Log (OPTIMAL) SURVEY.PAS Patient Activity Scale (PAS) SURVEY.PASII SURVEY.PCORNET Patient Activity Scale II (PAS-II) Patient Centered Outcomes Research Network (PCORnet) Common Data Model (CDM) SURVEY.PHQ Patient Health Questionnaire (PHQ) SURVEY.PROMIS Patient Reported Outcomes Measurement System (PROMIS) survey SURVEY.QRDA Quality Health Reporting Document Architecture (QRDA) survey SURVEY.RFC SURVEY.SAMHSA Residual Functional Capacity (RFC) survey Substance Abuse and Mental Health Services Administration (SAMHSA) survey SURVEY.USSGFHT United States Surgeon General Family Health Tool (USSGFHT) survey TIMP Test of Infant Motor Performance (TIMP) survey 120 LOINC® Users’ Guide - June 2016 Appendix C - Calculating Mod 10 Check Digits The LOINC code is a numeric code with a Mod 10 check digit. The algorithm for calculating a Mod 10 check digit is as follows: Instructions Example 1. Using the number 12345, assign positions to the digits, from right to left. 1st = 5 2nd = 4 3rd = 3 4th = 2 5th = 1 2. Take the odd digit positions counting from the right (1st, 3rd, 5th, etc.) 531 3. Multiply by 2. 1062 4. Take the even digit positions starting from the right (2nd, 4th, etc.). 42 5. Append (4) to the front of the results of (3). 421062 6. Add the digits of (5) together. 4+2+1+0+6+2 = 15 7. Find the next highest multiple of 10. 20 8. Subtract (6) from (7). Thus, 5 is the Mod 10 check digit for 12345. 20 - 15 = 5. Calculating the check digit for LOINC Parts, Answers, and other identifiers with characters We use a variant of the basic Mod 10 algorithm to calculate LOINC parts and answer identifiers because those identifiers contain the alpha prefixes “LP” and “LA” (which stand for LOINC Part and LOINC Answer). A detailed description of the method is available here: https://wiki.openmrs.org/display/docs/Check+Digit+Algorithm This same method could be used for calculating check digits for user-assigned “X codes” (that contain a leading “X” character) as well. 121 LOINC® Users’ Guide - June 2016 Appendix D - Procedure for Submitting Additions/Changes to LOINC Introduction Since its inception, LOINC has been developed as an open standard. We welcome requests for new terms! Submissions from LOINC users have helped us grow and adapt quickly. Likewise, we welcome suggestions for changes to existing terms or other enhancements like additional synonyms or term descriptions. Regenstrief balances the desire to respond quickly to new term submissions with the review processes necessary for a high quality standard. We can only be quick if the requesters provide clear and comprehensive information about the terms they are submitting. A list of information required for a submission is provided below. New requests are often for variations on observations we already have in the database. For example, there may be an existing term for a particular test result with serum as the specimen (system) and a user requests an identical term for a specimen of gastric contents. With the supporting information, these kinds of requests are usually straightforward. Please check the LOINC website pre-release page, “What’s Coming in the Next Release”, to see if there is a similar new term prior to submitting your request. Even when requesters provide complete information with their submission, some requests require discussion and decision by the LOINC Committee before Regenstrief completes them. These kinds of requests are for things like: (1) an entirely novel kind of measurement (2) use of LOINC codes in ways not previously agreed upon by the LOINC Committee Before you Submit Please note that we tend to avoid the use of methods for chemistry tests. We will not routinely accept requests for method-specific chemistry tests. Only in very special circumstances will we distinguish among analytic methods in chemistry. We do distinguish microbiology, serology, and coagulation tests by method type. Even here, however, we do not distinguish every variation in method. Look in the body of this User’s guide for information about the kinds of distinctions that we make. Note that our policy is to allow both method-vague (no method) as well as method-specific measures in serology (measures of Ab and Ag), and in antibiotic susceptibility testing. Please pay special attention to submissions that include the system of serum or plasma alone. For most chemical analyses there is no important clinical difference between the values obtained from serum and those obtained from plasma, and we would like to represent them in the database as Ser/Plas to indicate our indifference to the distinction. Unfortunately, many requesters of new terms define their request in terms of the one that they happen to use (e.g., serum or plasma) without telling us that the measure can really be done on either serum or plasma. Most such requests should be for Ser/Plas as the system (sample). If the measurement MUST be done on either serum or plasma, please scientifically justify your 122 LOINC® Users’ Guide - June 2016 request and send documentation; otherwise you will greatly delay our response to your submission. Survey instrument content has some additional complexity. If the instrument is copyrighted by a third party, Regenstrief will need to obtain permission prior to being able to model it in LOINC. In general, new LOINC terms are required for questions or variables that have different enumerated answer lists. How to Submit First things first The information you provide about your local test/measurement and how it is used is more important than the proposed LOINC name you come up with. Having complete information on what your local test is makes the review process much smoother and helps us create clear term definitions as well as verifying and enhancing other accessory content, which benefits everyone. The kinds of information we need does vary a bit depending on the type of content (lab, radiology, document titles, survey questionnaires, etc), so not all items are applicable all of the time. Format for submissions We recommend that you send requests using the RELMA generated file. If not RELMA, then you must use one of the templates available on the LOINC web site: http://loinc.org/submissions/new-terms The preferred method for submitting proposed LOINCs is using RELMA’s built-in functionality. See the section titled “RELMA Submission” below or review the RELMA manual for more details. Required information The set of information required for a particular submission depends on the content of the request. In order for us to process your request, we need: • • • • • • • • • • • • Local test/observation name Local order (panel) name Name of send out lab (if applicable) Name of healthcare organization that stimulated the request for this term (if you are submitting on behalf of someone else) Description of the test o For laboratory tests and clinical measurements, the description should indicate what is measured, how it is performed, and how it is used clinically (e.g. what conditions does it diagnose, monitor, screen for, etc.). o For other kinds of clinical terms, such as clinical documents, the description should indicate the expected information content that would be sent as the result value (i.e. what kinds of information this document or report contains). Units of measure (for quantitative observations) Answer lists (for qualitative observations) (both normal and abnormal answers) Sample results, reports (if applicable) If the request is for a panel, the request should include the tests that comprise the panel. Whether or not each test already has a LOINC code should be included, and for any tests that do not already have a code, all of the above information for each individual test should be provided Package inserts, test kit documentation (if applicable) Vendor, instrument, and/or reagent kit used to perform this test (if applicable) Description of the project or activity that stimulated the request for this term (e.g. IHE 123 LOINC® Users’ Guide - June 2016 • • • Antepartum Record Profile, Indiana Network for Patient Care health information exchange project, etc.) Implementation guide (for terms designed for use in the context of a specific messaging implementation guide) Original survey form (for questionnaires or survey content) Any other documentation that may assist us in creating the requested codes RELMA submission The RELMA program can aid you in creating submissions by allowing you to create, manage and store submission terms in a way that is similar to how the program creates, manages and stores local working sets. With RELMA, you can create terms for submission over time and submit groups of terms in batches. The program will track when the term was created and the date when you submitted the term. The program will help you organize the terms that you create and it will automate the process of creating the submission files. For detailed instructions on how to use the RELMA propose a term feature, please see Appendix A of the RELMA manual. You can be downloaded the RELMA Manual here: http://loinc.org/downloads/files/RELMAManual.pdf. Excel file submission If you are not using RELMA for submission, please use one of the templates provided on our website: http://loinc.org/submissions/new-terms Other formats (e.g. distributed database fields, exported internal/local formats) will not be accepted. Sending Submission Files to Regenstrief Institute Regardless of the file type, please email your submission and related documents to [email protected]. Within a day or two of receipt of your file, you will receive a confirmation email and the submission process will be underway. You may receive additional communication from Regenstrief with requests for further information if required. Once the submission process has completed, you will receive files containing your requested codes. 124 LOINC® Users’ Guide - June 2016 Appendix E - Examples for LOINC Property Matching 1. Content (Cnt). Like concentration except that volume in the denominator is replaced by mass. By extension: CCnt Catalytic Content, catalytic activity of a component per unit mass of a sample (system). 24048-1|Alpha galactosidase:CCnt:Pt:Fib:Qn MCnt Mass Content, mass of component per unit mass of a sample (system). 9435-9|Isopropanol:MCnt:Pt:Tiss:Qn Note: All of the heavy metal measurements in hair, nails, and tissue should all be mass contents. 8157-0|Arsenic:MCnt:Pt:Nail:Qn NCnt Number Content, number of component entities per unit mass of a sample (system). 20771-2|Coliform bacteria:NCnt:Pt:Egg:Qn:Viability count 2. Fraction (FR). Fraction of component A in a group of entities B, C, Y, N in system 1. By extension: CFr Catalytic Fraction 2536-1|Lactatedehydrogenase1/Lactatedehydrogenase.total:CFr:Pt:Ser/Plas:Qn:Electrophoresis 9642-0|Creatine Kinase.BB/Creatine kinase.total:CFr:Pt:Ser/Plas:Qn NFr Number Fraction 10602-1|Spermatozoa.abnormal head/100 spermatozoa:NFr:Pt:Semen:Qn 764-1|Neutrophils.band form/100 leukocytes:NFr:Pt:Bld:Qn:Manual count MFr Mass Fraction 2614-6|Methemoglobin/Hemoglobin.total:MFr:Pt:Bld:Qn SFr Substance Fraction 30192-9|Acetylcholine receptor modulation Ab/Acetylcholine Ab.total:SFr:Pt:Ser:Qn VFr Volume fraction. 4545-0|Hematocrit:VFr:Pt:Bld:Qn:Spun 3. Ratio (RTO). Ratio of component A to component B in system 1. By extension: CRto Catalytic Ratio (previously Catalytic Concentration Ratio, CCRto) 2325-9|Gamma glutamyl transferase/Aspartate aminotransferase:CRto:Pt:Ser/Plas:Qn SRto Substance Ratio (previously Substance Concentration Ratio, SCRto) 2958-7|Sodium/Potassium:SRto:Pt:Sweat:Qn MRto Mass Ratio (previously Mass Concentration Ratio, MCRto) 2768-0|Phenylalanine/Tyrosine:MRto:Pt:Ser/Plas:Qn NRto Number Ratio 11138-5|Myeloid cells/Erythroid cells:NRto:Pt:Bone mar:Qn VelRto Velocity Ratio 12022-0|Resistivity index:VelRto:Pt:Uterine artery.right:Qn:Doppler.calculated VRatRto Volume Rate Ratio 29462-9|Pulmonic flow/Systemic flow:VRatRto:Pt:Circulatory system.XXX:Qn:US.doppler Ratio 1811-9|Amylase/Creatinine renal clearance:Ratio:24H:Urine:Qn 125 LOINC® Users’ Guide - June 2016 Note: CSF/Serum Protein calculation is not a ratio, because the measured components are not in the same system. Its property type is relative mass concentration, RelMCnc (see below). Note: If the units of the denominator and numerator are both mass (e.g., mg/g), use MRto 13719-0|Carnitine/Creatinine:MRto:Pt:Urine:Qn If the units of the denominator and numerator are both substance (e.g., mmol/mol) use SRto 22695-1|Carnitine/Creatinine:SRto:Pt:Urine:Qn If the units of the denominator and numerator are different (mmol/g), use Ratio 17866-5|Carnitine/Creatinine:Ratio:Pt:Urine:Qn 4. Relative (REL). Relative amount of component A in system 1 compared to system 0. By extension: REL should be used anywhere an actual measurement is divided by a measurement on a normal or control. It should also be used when a quotient is created by dividing a measured substance in Serum by the same substance measured in CSF, Urine, etc. RelMCnc Relative Mass Concentration (as noted previously) 2858-9|Protein.CSF/Protein.serum:RelMCnc:Pt:Ser+CSF:Qn 3235-9|Coagulation factor XII Ag actual/Normal:RelMCnc:Pt:PPP:Qn:Imm RelTime Relative time 3232-6|Coagulation factor XII activity actual/Normal:RelTime:Pt:PPP:Qn:Coag RelCCnc Relative Catalytic Concentration 28660-9|Plasminogen actual/Normal:RelCCnc:Pt:PPP:Qn:Chromo RelRto Relative Ratio 1756-6|Albumin.CSF/Albumin.SerPl:RelRto:Pt:Ser/Plas+CSF:Qn RelVol Relative Volume 19853-1|Capacity.inspiratory.bs/Capacity.inspiratory.preop:RelVol:Pt:Respiratorysystem:Qn:Spirometry RelVrat Relative Volume Rate 20161-6|Voluntaryventilation.max^postbronchodilator/MVV:predicted:RelVRat:Pt:Respiratory system:Qn 5. Cmplx. Other divisions of one measurement by another that are not covered by the above rules should be classed as having Complex (Cmplx) properties, and the exact formula for deriving the quantity should be explicitly stated. 6. Arbitrary. Arbitrary concentration of items. If we are not measuring the activity of an enzyme then the units of measure and properties are: Possible Values Units/mL, IU/mL, etc. Units/gm, IU/gm, etc. Unit/min, IU/24hr, etc. Unitless (Patient/Control) Property Scale ACnc ACnt ARat AFr Qn Qn Qn Qn 126 LOINC® Users’ Guide - June 2016 NOTE: If we are measuring the activity of an enzyme then the units of measure and properties are: Possible Values Property U/mL, Units/mL, etc. U/gm, Units/gm, etc. U/24hr, Unit/min, etc. Unitless (Patient/Control) Scale CCnc CCnt CRat CFr Qn Qn Qn Qn 7. If the property is Titr then the scale is always Qn. For any X Ab or Ag: Possible Values Property <1:2, 1:4, 1:8... Scale Titr Qn 8. For Any X Ab or Ag: Possible Values Property Scale Neg, Indeterminate, Pos 1+, 2+, 3+... <1:2, 1:4, 1:8... Neg, 1:4, 1:8 ... Neg, 0.90 … PrThr PrThr Titr Titr ACnc Qn Qn Qn Ord Ord (EIA units) 9. For any intensive evaluation whose value comes from a finite set of unranked (independent) coded items the property will be Prid (or Type) and scale Nom. Prid is used in cases where the value set includes the option of reporting “none”, “not present”, etc. Type is used in cases where the result always specifies a value from the finite set. For extensive measures whose value comes from a finite set of unranked coded items, the property will be the extensive property, and the scale will be Nom. Intensive Properties Possible Values (coded) Organism Identified E. coli, S. aureus, etc. ABO Group A, B, AB, O Surgery (Dis. Summary) Cholecystectomy, Appendectomy Extensive Properties Urine Color Possible Values (coded) Amber, straw, etc. Property Scale Prid Type Prid Nom Nom Nom Property Scale Type Nom 10. For any intensive evaluation whose value comes from a finite set of unranked (independent) free text items (or a paragraph) the property will be Prid, or Find and scale Nar to indicate that the result is free text narrative. For extensive measures whose value comes from a finite set of unranked text items (or a paragraph), the property will be the extensive property, and the scale will be Nar. Intensive Properties Possible Values (text) Organism Identified ABO Group Surgery (Dis. Summary) E. coli, S. aureus, etc. A, B, AB, O Cholecystectomy Extensive Properties Possible Values (text) Urine Color Amber, straw, etc. 127 Property Prid Type Prid Scale Nar Nar Nar Property Scale Type Nar LOINC® Users’ Guide - June 2016 11. Imp is used to represent the property when the evaluation is a mental abstraction based on one a collection of measurements and or data. For example, if several measurements are made relative to immunoglobin levels in Serum and CSF in a myasthenia gravis panel, and if by examining all of the evidence a pathologist decided that this pattern of findings represented active disease (which could be represented as a coded value), the result of the pathologist thought process would be represented as: Possible Values (text) Myasthenia Evaluation No disease, chronic disease Property Scale Imp Nom If the pathologist evaluation is reported free text or a paragraph of information, the representation would be: Myasthenia Evaluation No disease, chronic disease Imp Nar 12. Methods are only used to distinguish things that are identical in the other five LOINC fields but may differ because the sensitivity or specificity is different for the given methods. 13. Need to be careful in distinguishing end point detection method from property. For example, if sodium is measured using an ion specific electrode, the property is not a voltage difference. The voltage difference is just a method for indirectly measuring the sodium concentration. Concentration is the real property. Likewise, many antigens and antibodies are now measured using optical density as the detection method. However, the property we are really measuring is an arbitrary concentration (ACnc), not the optical density. If it is a ratio of optical densities (as with Gliadin Ab, Parvovirus B19 Ab, etc.) that are compared (patient value divided by a standard control), then the property should be RelACnc (relative arbitrary concentration). 14. ml/min/1.73sqM (Milliliters per min per 1.73 square meters BSA): Similar to the immediately preceding item. This result has the same property as if it had units of ml/min/sqM. The property of this measurement should be called “areic volume rate” (ArVRat). 128 LOINC® Users’ Guide - June 2016 Appendix F – Example Acronyms used in LOINC Table 33: Example Acronyms used in LOINC Acronym Meaning AC Abdominal Circumference ADL Activities of Daily Living AE Anion Exchange protein AP Anterio-Posterior APAD AnteroPosterior Diameter of the Abdomen AUT Automated Ultrasound Testing B2GP1 Beta 2 Glycoprotein 1 BD Binocular Distance BOR Brachio-Oto-Renal BPC Biparietal Circumference BPD Biparietal diameter CD Cluster of differentiation CDA Congenital dyserythropoietic anaemia CDB Childhood Disability Benefits cDNA complementary DNA CFst Cine Calorie Fast Civilian Health and Medical Program of the Uniformed Services Cinematographic CMS Centers for Medicaid and Medicare Services CNR1 Cannabinoid receptor 1 COC Commission on Cancer COPD Chronic Obstructive Pulmonary Disease CPT Current Procedural Terminology CRL Crown-Rump Length CSF Cerebral spinal fluid CW Continuous wave CyCD22 Cytoplasmic CD22 DBG Donna Bennett-Goodspeed DCIS Ductal carcinoma in situ DISIDA Diisopropyliminodiacetic acid DRG Diagnostic Related Groups DTPA Diethylenetriamine pentaacetate Dx Diagnosis EBV-LMP Epstein Barr virus – latent membrane protein ED Emergency Department EDD Estimated Delivery Date EEG Electroencephalogram EFW Estimated Fetal Weight EGD Esophagogastro duodenoscopy EKG Electrocardiogram EMS Emergency Medical Service(s) CHAMPUS 129 LOINC® Users’ Guide - June 2016 ENT Ear, Nose Throat ERCP Endoscopic Retrograde Cholangiopancreatography FL Femur Length FLACC Face Legs Activity Cry Consolability FNA Fine Needle Aspirates FTA Fetal Trunk Area GALOP Gait disorder Autoantibody Late-age Onset Polyneuropathy GSD Gestational Sac Diameter GSL Gestational Sac Length HC Head Circumference HIV Human immunodeficiency virus HIV-SSC Sign and Symptom Check-List for Persons with HIV Disease HL Humerus Length HLA Human Leukocyte Antigen HMPAO Hexamethylpropyleneamine oxime HTLV Human T-cell Lymphotropic Virus HWL Height Width Length ICD International Classification of Diseases ICD9 ICD-O International Classification of Diseases, Ninth Revision International Classification of Diseases, Ninth Revision, Clinical Modification International Classification of Diseases for Oncology ID Intradermal INR International normalized ratio IOD Inter Ocular Distance KUB Kidney-Ureter-Bladder LHON Leber hereditary optic neuropathy LOINC Logical Observation Identifiers Names and Codes LVOT Left Ventricular Outflow Tract LW Landsteiner-Wiener LWT Length Width Thickness MAA Microalbumin aggregate albumin MEMS Medication Event Monitoring System MERSTH Medical Event Reporting System-Total Health System MIB-1 Mindbomb homolog 1 MIBG Metaiodobenzylguanidine MIC Minimum inhibitory concentration MLC Minimum lethal concentration MLO Mediolateral oblique MMA Macro aggregate albumin MVV Maximum Voluntary Ventilation NAACCR North American Association of Central Cancer Registries Ng Nasogastric NPI National Provider Identifier OFD Occipital-Frontal Diameter O-I BPD Outer to Inner Biparietal Diameter OmpC Outer membrane porin of E coli ICD9-CM 130 LOINC® Users’ Guide - June 2016 O-O BPD Outer to Outer Biparietal Diameter O-O TD Outer to Outer Tympanum Diameter OOD Outer Orbital Diameter PA Postero-Anterior PCP Primary Care Physician PEG Polyethylene Glycol PHQ Patient Health Questionnaire PISA Proximal Isovelocity Surface Area PSR Peridontal Screening and Recording PYP Pyrophosphate QAM Quality Audit Marker QID Four times a day RAST Radioallergosorbent test RFC Residual Functional Capacity RFLP Restriction fragment length polymorphism RUG Resource Utilization Groups SAB Streptoavidin-biotin SBT Sequence based typing SC Sulphur colloid SCB Sertoli cell barrier SCL Scleroderma SEER Surveillance Epidemiology and End Result TAD Transverse Abdominal Diameter TC Thoracic Circumference TCD Transverse Cerebellar Diameter TD Transaxial Diameter TEC Tubingen electric campimetry TID Three times a day TNM TTD Tumor, node, metastasis Toxoplasma, Rubella. Cytomegalovirus, Herpes Simplex Virus Transverse Thoracic Diameter TU Tuberculin Units VTI Velocity Time Integral VWF von Willebrand Factor TORCH 131 LOINC® Users’ Guide - June 2016 Appendix G – LOINC Technical Briefs Technical briefs have been developed for various LOINC terms to clarify either the meaning, current nomenclature, or use case of a given term. The following technical briefs are included in this manual and linked to related LOINC terms in RELMA. D-Dimer Revisions in LOINC Author: J. Gilbert Hill, MD, PhD Cockcroft-Gault formula for estimating creatinine clearance, Schwartz equation for Glomerular Filtration Rate and MDRD formulae Authors: Gilbert Hill, MD, PhD with edits by Clement J McDonald, MD Inducible Clindamycin Resistance in Staphylococcus and Streptococcus Author: David Baorto, MD, PhD KIR Gene Family Author: David Baorto, MD, PhD Oxygen Saturation and LOINC Authors: Gilbert Hill, MD, PhD and Clement J McDonald, MD Nomenclature of Salmonella Species, Subspecies, and Serovars Author: David Baorto, MD, PhD Segmented Neutrophils versus Polymorphonuclear WBC Author: David Baorto, MD, PhD Vitamin D Summary Author: David Baorto, MD, PhD Free Thyroxine Index Variants Author: David Baorto, MD, PhD 132 LOINC® Users’ Guide - June 2016 D-DIMER 2006-11-24 The Problem: For many years a test known as "D-dimer" has been used for the assessment of patients with DIC, and more recently, for the exclusion of the diagnosis of DVT or PE. The units used in expressing results are usually ng/mL or ug/L, so that a report might look like: D-dimer = nn ug/L or D-dimer = nn ng/mL Occasionally, this expression is modified to read D-dimer = nn ug/L DDU, (where the DDU stands for D-dimer units) With time, new test procedures have been developed, in which newer methods of analysis and of preparation of the test standard have led to the use of new "units" in expressing results. With these reagent sets, a report might look like: D-dimer = xx FEU ug/L or D-dimer = xx ug FEU/L or D-dimer = xx ug/L FEU, (where FEU is an acronym for fibrinogen equivalent units) The location of FEU in the unit is not consistent: some users place the FEU before the "ug", some after the "ug", and some after the "L". From a clinical perspective, the D-dimer test is potentially of greatest value in ruling out DVT or PE: for results expressed as ng/mL (= ug/L) the exclusion value is generally less than 250; for results expressed as ng/mL FEU, the exclusion value is less than 500, and these values are compatible with a rule-of-thumb conversion published by Biomerieux, July 2003: 600 ng/mL FEU = 300 ng/mL D-dimer. So . . . now we have the use of single name for a test - D-dimer - but with results falling into two separate families. The difference between the two families is that the results differ by a factor of approximately two. This has led to a chaotic situation in the lab, and by extension, to the bedside, a situation in which both laboratory staff and clinicians are confused as to what "D-dimer" is being measured and reported. The world-wide web has dozens of references to the problem, and the CAP has commented frequently, with a series of feature articles in CAP Today (Feb 2000, Jan 2003, April 2005, May 2005, Summer 2005). In LOINC terms, we have a component representing two different entities, with identical primary attributes (component, property, scale, system, time aspect and scale), differentiated only by method and units, both of which are very weak discriminators. The fundamental problem is the lack of a useful standard. The International Society on Thrombosis and Haemostasis has had a subcommittee working for more than ten years on D-dimer standardization, without success, and it is said that a seat on the 133 LOINC® Users’ Guide - June 2016 committee comes with retirement benefits. The following figures provide an estimate of the scope of the problem: in a 2004 US (CAP) survey, 59% of labs reported FEU, 41% reported D-DU and 8% did not know the units they were using; in a 2005 Canadian (QMPLS) survey, 68% of labs reported D-DU, 31% reported FEU, and 1% did not know the units they were using. Resolving the Problem The obvious solution to the problem is to have different names for the two "families" of D dimer. But what should these names be? Contributing to the original problem is the unfortunate choice of the acronym FEU, for fibrinogen equivalent units. The inclusion of the word "unit" gives the impression that FEU is a unit in the metrological sense, whereas it would be more reasonable to think of it as a unit in the structural sense - e.g., a unit such as glucose in a larger molecule such as starch. Given this interpretation, FEU may be more closely related to, or equivalent to the "component" (in the LOINCian sense), rather than to the metrological unit. In other words, FEU is the name of what is measured: just as the amount of glucose can be measured in a sample, so can the amount of FEU. From this it is logical to propose that existing entries in LOINC retain the component name FIBRIN D-DIMER, but that a new entry be created with the name FIBRIN D-DIMER.FEU. In accordance with LOINC naming conventions, a dot (.) separates the analyte name from the "subspecies". This proposed name protects the connection with the D-dimer family, but efficiently separates it as a different entity. The fully specified name would be FIBRIN D-DIMER.FEU:MCNC:PT:PPP:QN:EIA There is at least one precedent in LOINC for this type of component modification - see LOINC 4539-3, Erythrocyte Sedimentation Rate.Zeta. The quantitative D-dimer entries in LOINC 2.17 are as follows: 134 LOINC® Users’ Guide - June 2016 D-dimer results from American Proficiency Institute 2004 Testing Program These tables hint at some of the problems associated with the measurement of Ddimer, in particular the inaccuracy and imprecision, but also proved a convenient example of the problem under discussion: Biomerieux pioneered the use of the acronym FEU, but Biomerieux results are shown in the first, ug/L table, rather than the second, ug FEU/mL table. 135 LOINC® Users’ Guide - June 2016 136 LOINC® Users’ Guide - June 2016 Cockcroft-Gault formula for estimating creatinine clearance, Schwartz equation for Glomerular Filtration Rate and MDRD formulae Authors: Gilbert Hill, MD, PhD with edits by Clement J McDonald, MD Written: 11/20/2007 1 Estimating creatinine clearance from serum creatinine 1.1 Cockcroft-Gault – not adjusted for body surface area (BSA) The Cockcroft-Gault formula is used to estimate creatinine clearance from age, weight and serum creatinine. The original paper from these two authors was Prediction of Creatinine Clearance from Serum Creatinine, Nephron 1976;16:31- 41 hence the name. Note that Creatinine clearance is a proxy for Glomerular Filtration Rate (GFR) and some clinical settings describe this as an estimated GFR (see below). The basic formula without normalization for BSA is represented in the LOINC data base by the following term. 35591-7 Creatinine renal clearance.predicted VRat Pt Ser/Plas Qn Cockcroft-Gault formula And the formula is as follows The equation as shown requires weight to be recorded in kg and creatinine in mg/dL, and is valid for male patients. If the patient is female, the result should be multiplied by 0.85. Web calculator for creatinine in mg/dL If the patient’s weight is recorded in kg and the creatinine is reported in umol/L then results from the above equation must be multiplied by 1.23 for men and 1.04 in women. Web calculator for creatinine in umol/L From http://www.sydpath.stvincents.com.au/other/CalcsCrClCGumol.htm 1.2 Cockcroft-Gault – adjusted for body surface area It is now common practice for the creatinine clearance calculated by the Cockcroft-Gault formula to be normalized for a body surface area of 1.73 m2. 137 LOINC® Users’ Guide - June 2016 In particular, the Cockcroft-Gault BSA adjusted formula is used by many pharmacy departments for medication dosage adjustments. LOINC terms for BSA adjusted creatinine clearance 35592-5 Creatinine renal clearance/1.73 sq M.predicted VRat Pt Ser/Plas Qn 50380-5 Creatinine renal clearance/1.73 sq M.predicted.female VRat 24H Ser/Plas Qn 50381-3 Creatinine renal clearance/1.73 sq M.predicted.male VRat 24H Ser/Plas Qn Cockcroft-Gault formula, corrected for BSA Cockcroft-Gault formula, corrected for BSA Cockcroft-Gault formula, corrected for BSA 2 Direct prediction of GFR 2.1 Creatinine-based prediction of GFR 2.1.1 Schwartz formula for Pediatrics The Schwartz formula is used to predict GFR in pediatrics. The original paper by G F Schwartz et al, is A Simple Estimate of GFR in Children Using Body Length and Plasma Creatinine, Pediatrics 1976;58:259-263 has become more relevant in the last few years because the MDRD formula (below) is specifically stated NOT to be applicable to patients under 18 years of age. The Schwartz formula depends on age, sex, and body height and serum creatinine. The equation can be stated as follows: GFR Calculator for Children Schwartz Formula GFR (mL/min/1.73 m2) = k (Height) / Serum Creatinine k = Constant o k = 0.33 in Preemie Infants o k = 0.45 in Term infants to 1 year old o k = 0.55 in Children to 13 years o k = 0.65 in Adolescent males (Not females because of the presumed increase in male muscle mass. The constant remains .55 for females.) Height in cm Serum Creatinine in mg/dl Web calculator for Schwartz Formula LOINC term for Schwartz formula 50384-7 Glomerular filtration rate/1.73 sq M.predicted VRat 24H 138 Ser/Plas Qn Creatinine-based formula (Schwartz) LOINC® Users’ Guide - June 2016 2.1.2 MDRD 4 variables The MDRD 4 variable equation is the principle equation recommended by professional nephrology societies to estimate the GFR. It depends upon serum creatinine, age, sex and race. It also includes a BSA adjustment term of 1.73 - the average body surface area in an adult male. (Equations incorporating height and weight can be used to correct this equation when patients are far from the mean in BSA- but are not routinely used. The following is (taken from NKF MDR web site ) The National Kidney Disease Education Program (NKDEP) of the National Institute of Diabetes and Diseases of the Kidney (NIDDK), National Kidney Foundation (NKF) and American Society of Nephrology (ASN) recommend estimating GFR from serum creatinine using the MDRD Study equation. This equation depends upon the serum creatinine age, sex and race to estimate the GFR and therefore improves upon several of the limitations with the use of serum creatinine alone. The MDRD Study equation has been rigorously developed and validated, and is more accurate than measured creatinine clearance from 24-hour urine collections. The equation is: GFR = 186 x (PCr)-1.154 x (age)-0.203 x (0.742 if female) x (1.210 if black) GFR is expressed in ml/min/1.73 m2. , In this equation Pcr serum creatinine must be expressed in mg/dl, and age in years. (Of course other units can be used if the right side of the above equation is multiplied by the appropriate constant). (all taken from NKF web site http://www.kidney.org/professionals/KLS/gfr.cfm#2 December 04 2006) Web calculator for MDRD The glomerular filtration rate predicted by the MDRD formula may be reported in at least 3 ways: a) All four variables are known and used in the equation. The result would be race and sex adjusted creatinine clearance. b) Only two variables (serum creatinine and age) are used in the equation. In this circumstance, the report may: i) include a comment saying – “if patient is black, multiply result by 1.21” and/or “if patient is female, multiply the result by .742” or ii) may include two values: N1 if white and N2 if black, and a correction factor for sex: if patient is female, multiply the result by .742. LOINC codes for MDRD formula 33914-3 48642-3 48643-1 50044-7 Glomerular filtration rate/1.73 sq M.predicted Glomerular filtration rate/1.73 sq M.predicted.non black Glomerular filtration rate/1.73 sq M.predicted.black Glomerular filtration rate/1.73. sq M.predicted.female VRat Pt Ser/Plas Qn VRat Pt Ser/Plas Qn VRat Pt Ser/Plas Qn VRat Pt Ser/Plas Qn 139 Creatinine-based formula (MDRD) Creatinine-based formula (MDRD) Creatinine-based formula (MDRD) Creatinine-based formula (MDRD) LOINC® Users’ Guide - June 2016 2.1.3 MDRD 6 variables A six variable version of the MDRD exists. This one depends on the patient’s serum albumin and serum urea nitrogen values in addition to the MDRD-4 variables, but is not the preferred equation for this estimate. Where PCr=serum creatinine concentration (mg/dl) (alkaline picrate method); SUN=serum urea nitrogen concentration (mg/dl) (urease method); Alb=serum albumin concentration (g/dl) (bromocresol green method). Taken from: Stoves J,Lindley E,Barnfield M,Burniston T, Newstead C. MDRD equation estimates of glomerular filtration rate in potential living kidney donors and renal transplant recipients with impaired graft function.Nephrol Dial Transplant.2002,17: 2036-2037 2.2 Cystatin-based prediction of GFR Although the MDRD equation, based on the measurement of serum creatinine, is the most widely used method for estimating GFR, an alternative, based on the measurement of serum cystatin is claimed to have certain advantages. Estimating Glomerular Filtration Rate in Kidney Transplantation: A Comparison between Serum Creatinine and Cystatin C-Based Methods, J Am Soc Nephrol 16: 3763– 3770, 2005 Web calculator for Cystatin-based GFR LOINC code for GFR predicted by a cystatin-based formula 50210-4 Glomerular filtration rate/1.73 sq M.predicted VRat Pt 140 Ser/Plas Qn Cystatin-based formula LOINC® Users’ Guide - June 2016 Inducible Clindamycin Resistance in Staphylococcus and Streptococcus Author: David Baorto, MD, PhD Written: 5/12/2011 Macrolide-Lincosamide-Streptogramin B (MLSb) Resistance There is a phenomenon by which the organism can appear to be susceptible to lincosamindes such as clindamycin when tested in vitro, yet exposure to an appropriate macrolide (such as erythromycin) can INDUCE resistance to the clindamycin. This mechanism of resistance involves methylation of the 23S rRNA binding site that is shared by 3 antibiotic classes (macrolides, lincosamides, and group B streptogramins) and prevents their binding to the site and exerting their effect. This resistance mechanism is known (for short) as MLSB. When one of the erm methylases is produced constitutively, the resistance is constitutive and requires no induction. However, in some cases, the translation of the erm methylase protein is suppressed and is activated only after the binding of a macrolide antibiotic to upstream sequences, which alters the mRNA conformation, allowing it to be translated. Once this occurs, active methylase enzyme is produced which methylates the binding site for all 3 antibiotic classes, potentially preventing the binding of any of these antibiotic classes and inducing co-resistance. Detection of this resistance pattern can be detected phenotypically using disc diffusion (Clindamycin.induced [Susceptibility] by Disk diffusion (KB), 42720-3). The detection of the presence of either the ermA or ermC gene The methylase enzyme is encoded by one of the erm genes, generally ermA or ermC in staph, ermB in strep. Finding ermA or ermC similarly indicates the possibility for resistance to both erythromycin and clindamycin in Staph (either constitutive or inducible for clinda), so reporting both genes has been combined in some assays to indicate that one of the two has been detected (Bacterial erythromyin+clindamycin resistance (ermA + ermC) genes [Presence] by Probe & target amplification method, 62258-9). 141 LOINC® Users’ Guide - June 2016 The KIR Gene Family Author: David Baorto, MD, PhD Written: 4/17/2011 Clinical Significance KIR (Killer cell Immunoglobulin-like Receptor) molecules, a novel category of lymphocyte receptors, are predominantly found on the surface of natural killer (NK) cells. Through their interaction with HLA class I molecules, they modulate NK cell activity, central to the ability of those cells to distinguish between healthy cells and those either infected or transformed. The KIR family of molecules demonstrates extensive diversity at the gene level, stemming from multiple genes as well as multiple alleles. As a result of this polymorphism, KIR genotype is unlikely to be identical between individuals (in a sense similar to their molecular ligand, HLA Class I). The relationship between KIR genotype and disease is beginning to be elucidated, and is likely to interact with HLA. Needless to say it is a growing area, but there is evidence that which KIR genes are expressed in an individual may be related to susceptibility to infections (e.g, HCV, HIV), autoimmune diseases, and certain cancers. Importantly, the success of hematopoietic cell transplantation for some leukemias may be closely tied to KIR type or KIR compatibility, and be an additional predictor (with HLA). Nomenclature of KIR genes and alleles The KIR genes have been classified under the CD nomenclature as a set of CD158 molecules (CD158a, CD158b, etc.), but the CD names are not commonly used because they do not specifically reflect structure, function and gene polymorphism. The frequently used KIR gene nomenclature is developed by the HUGO Genome Nomenclature committee (HGNC). It includes over 15 genes and is based on molecular structure. They all begin with “KIR”, the next digit is the number of Immunoglobulin-like domains, next is “D” for domain, next is a description of the cytoplasmic tail, either “L” for long, “S” for short, or “P” for pseudogenes. The last digit is an integer to distinguish among different KIR genes having that same structure. (e.g. KIR2DL1, KIR2DL2, etc). Different alleles of a KIR gene are named in a fashion similar to that of HLA alleles, with an asterisk following the gene name, followed by digits indicating differences in encoded proteins and non-coding regions. References: Marsh S G, Parham P, Dupont B, Geraghty D E, Trowsdale J, Middleton D, Vilches C, Carrington M, Witt C, Guethlein L A, Shilling H, Garcia C A, Hsu K C, Wain H. Killer-cell immunoglobulin-like receptor (KIR) nomenclature report, 2002. Immunogenetics 2003; 55(4):220-226. [PMID: 12838378] Parham P. MHC class I molecules and KIRs in human history, health and survival. Nat Rev Immunol. 2005; 5(3):201-214. [PMID: 15719024] Carrington M, Norman P. The KIR Gene Cluster. Bethesda (MD): National Center for Biotechnology Information (US); May 28, 2003. [PMID: NBK10135] 142 LOINC® Users’ Guide - June 2016 Oxygen Saturation and LOINC® Authors: Gilbert Hill and Clement J. McDonald Written: 10/19/2007 – Revised: 7/9/2009 (See NCCLS 46-A Blood Gas and pH Analysis and Related Measurements: Approved Guideline.) 1. Oxygen saturation The term “oxygen saturation" is often used to refer to two distinctly different quantities, hemoglobin oxygen saturation (recommended symbol = sO2) and fractional oxyhemoglobin (recommended symbol = FO2Hb). 2. NCCLS 46-A defines the two as follows: 2.1 Hemoglobin oxygen saturation Hemoglobin oxygen saturation = the amount of oxyhemoglobin in blood expressed as a percent of the total amount of hemoglobin able to bind oxygen (i.e. oxyhemoglobin (O2Hb) + deoxyhemoglobin (HHb). Note that carboxyhemoglobin (COHb), methemoglobin (MetHb) and Sulfhemoglobin (SulfHb), the socalled dyshemoglobins (dysHb) are unable to bind oxygen, so are not included in the denominator of this fraction sO2 = 100 x O2Hb/(O2Hb + HHb) More important some instruments, e.g. the pulse oximeter- can not pick up the dyshemoglobins. So they always report sO2 This quantity may be referred to as "oxygen saturation", Terms such as "functional" oxygen saturation or oxygen saturation of "available" or "active" hemoglobin, but NCCLS should not be used to name this quantity... 2.2 Fractional oxyhemoglobin Fractional oxyhemoglobin = the amount of oxyhemoglobin expressed as a percent of the total hemoglobin (where total Hb = O2Hb + HHb + [COHb + MetHb + SulfHb] taken all together O2Hb HHb and the three DysHb's represent the total Hb. FO2Hb = O2Hb/tHb A key point here is that it takes a more sophisticated machine to measure Fractional Oxyhemoglobin than sO2. 3. When there are no dyshemoglobins present (the usual situation), sO2 = FO2Hb 4. Oxygen saturation obtained by measuring pH and pO2 An “oxygen saturation" can also be obtained by measuring pH and pO2 and substituting the values into an empirical formula for the oxyhemoglobin dissociation curve (Hill equation). However, this calculated approach is prone to many kinds of errors and “oximetry” based on differential spectrophotometry is now the method of choice. 143 LOINC® Users’ Guide - June 2016 5. Three principal classes of oximetry There are at least three principal classes of oximetry, commonly known as: Pulse (or transcutaneous) oximetry (sensor attached to body surface) Hemoximetry (sample of blood injected into instrument) Co-oximetry. Historically a Co-oximeter measures Carbon monoxide bound hemoglobin’s and the other two dyshemoglobins and could only be done in the laboratory with an injected blood sample Today ( 2009) most laboratory blood analyzers measure all three dyshemoglobins and are really Co-oximeters, but may not be named as such. A pulse co-oximeter was placed on the market in 2005 this devise reports the both oxyhemoglobin %, Carbon monoxide %, the Pleth variability index, it also measures each of the dyshemoglobins. So it provides an accurate fractional oxygen saturation as well as information about CO poisoning. 6. Instruments used for pulse and hemoximetry The instruments used for pulse and hemoximetry base results on calculations from readings at two different wavelengths, which means they do not reflect the presence of any dyshemoglobins, and therefore the result they produce will be sO2 (LOINC component Oxygen saturation = NCCLS hemoglobin oxygen saturation). 7. Instruments used for co-oximetry The instruments used for co-oximetry base results on calculations from readings at four to eight different wavelengths, which means they are able to reflect the presence of any dyshemoglobins, and therefore the result they produce will be FO2Hb (LOINC component Oxyhemoglobin/Hemoglobin. total = NCCLS fractional oxyhemoglobin). LOINC will name its components according to the NCCLS recommendation, and apply the corresponding NCCLS synonyms i.e. sO2 and FO2HB to the components, oxygen saturation and Hemoglobin Oxygen fraction, respectively and include the defining equation (see above) for the terms that carry these respective components. We will retain oxygen saturation as a synonym for both sO2 and FO2Hb so that mappers who may not know the official names will still be able to find the terms. LOINC will use the property of MFR (mass fraction) to identify the property of these terms.. There would only be an imperceptible difference between the numerical representation of this quantity as a MFR versus an SFR (substance or molar fraction), By LOINC convention we use MFR rather than SFR in such cases. Depending upon the naming precision of laboratory, it may be difficult to determine whether a result called an Oxygen saturation is really an sO2 or FO2Hb, The other tests in the panel, and the inclusion of method names in the test order or battery and the source of the term (clinical laboratory, cardiac cath laboratory, respiratory therapy, nursing) all provide guidance for the mapping. But it may be necessary to contact the source to be sure in some cases. If a battery reports both a fractional oxyhemoglobin and oxygen saturation the situation should be clear. If the method is co-oximetry or the batter includes a separate measure of Carboxyhemoglobin (or any of the other dyshemoglobins) then the will be reporting a fractional oxyhemoglobin. If the method is pulse oximetry- then you have a sO2. Most central and ICU based blood gas measures will produce a fractional oxyhemoglobin. 144 LOINC® Users’ Guide - June 2016 Finally, in the U.S. these results are almost always reported with units of percent (%), but these results are reported as pure fractions (E.g. 20% becomes 0.2) in some environments. 145 LOINC® Users’ Guide - June 2016 Nomenclature of Salmonella Species, Subspecies, and Serovars Author: David Baorto, MD, PhD Written: 7/9/2011 Salmonella nomenclature is complex and has caused confusion. At the present time, by molecular methods the genus Salmonella is known to have only 2 species: Salmonella enterica and Salmonella bongori. Salmonella enterica is divided into 6 subspecies, each of which is further divided into numerous serovars (or serotypes) based on serological testing of somatic(O) and flagellar(H) antigens. Serovars are then designated by a formulaic concatenation of the antigens, known as the “antigenic formula”. The terms “serovar” and “serotype” appear to be used interchangeably, however, there has been a preference expressed for the term “serovar” by the Association of Public Health Laboratories and the World Health Organization (which uses “serovar” in its documentation). As a result, that will be the term used in this document. A significant number of what are now known to be serovars were originally thought to be distinct species of Salmonella, and those species names became rooted in common clinical usage. As a result, Salmonella nomenclature deviates from that of other bacteria, which, for the most part, do not have common names assigned to serovars. (Even the well-known E. coli O157:H7 is known by its antigenic formula.) Salmonella, on the other hand consists of 2579 individual serovars (2007 WHO documentation), about 1400 of which have common names. Here is where it gets tricky(er). While it would be impractical to eradicate commonly used names for important serovars, formatting is used to indicate that the names are not that of species, generally by NOT italicizing and instead capitalizing the first letter of the serovar name as follows: “Salmonella enterica subsp. enterica serovar Typhimurium”. Since all the commonly named serovars are in the subspecies enterica, that middle designation can be left off, resulting in the name “Salmonella enteric serovar Typhimurium”. LOINC ® Terms Associated with Salmonella Serotyping: Salmonella sp identified [Type] in Isolate (59846-6) This code has one of 7 possible answers to differentiate the 2 species and 6 subspecies in the case of enterica. When performed by the CDC, the answer is derived from a series of about 50 biochemical tests and consists of 7 possibilities: Salmonella enterica subspecies enterica (type I ) Salmonella enterica subspecies salamae(type II ) Salmonella enterica subspecies arizonae(type IIIa ) Salmonella enterica subspecies diarizonae(type IIIb ) Salmonella enterica subspecies houtenae(type IV ) Salmonella bongori Salmonella enterica subspecies indica(type VI) Salmonella sp antigenic formula [Identifier] in Isolate by Agglutination (56475-7) This code has a discrete set of over 2500 possible answers representing the antigenic formula 146 LOINC® Users’ Guide - June 2016 concatenated from the O and H antigens and sometimes other antigens found by agglutination testing. This code is intended to report only the antigenic formulae of the serovar, not the common name for the serovar. The format of the antigenic formula generally is expected to contain the subspecies type (I,II,IIIa, etc), then followed by somatic (O) antigens, flagellar (H) phase 1 antigens, flagellar (H) phase 2 antigens, and other antigens separated by a colon. So, a Salmonella type IV (Salmonella enteric subspecies houtenae) with O antigen 43 and H (phase 1) antigens z36, z38 would be reported as “IV 43:z36,z38:-“. Salmonella sp serovar [Type] in Isolate (65756-9) This code is intended to report a final answer for the serovar found, thus has an answer list similar in size to 56475-7. It will report the common name for the antigenic formula reported by that code (if there is a common name). If there is no common name, it will report the antigenic formula. In about 90% of cases the antigenic formula reported by 56475-7 will cleanly map to a serovar to report by this code. In the remaining 10% of cases, however, serovars can be further distinguished even in the light of identical antigenic formulas. These distinctions can involve further biochemical testing or sometimes further antigen testing. 147 LOINC® Users’ Guide - June 2016 Segmented Neutrophils Versus Polymorphonuclear WBC Author: David Baorto, MD, PhD Written: 4/17/2011 Segmented neutrophils are commonly referred to as polymorphonuclear neutrophils, PMNs, or “polys”. Therefore, in common usage the term polymorphonuclear leukocyte (or polymorphonuclear WBC) refers to neutrophils. Caution coding in this area should be applied because there is a usage whereby all granulocytes, including neutrophils, basophils and eosinophils, can be referred to as polymorphonuclear cells” due to the variable shape of their nuclei. Basophils can therefore be referred to as polymorphonuclear basophil (PMB), eosinophils as polymorphonuclear eosinophils (PME), in addition to neutrophils (polymorphonuclear neutrophil, PMN). Refer to the following Wikipedia page for more information: http://en.wikipedia.org/wiki/Granulocyte 148 LOINC® Users’ Guide - June 2016 Vitamin D Author: David Baorto, MD, PhD Written: 2/19/2011 General Summary Vitamin D is a prohormone that is involved in calcium and phosphate homeostasis, bone formation, and immune regulation. The determination of vitamin D is complex because it is not a single component, but has 2 major forms, each of which has several metabolic stages leading to an active end product. Vitamin D3, also known as cholecalciferol, is the form that occurs naturally in humans and is produced in the skin of vertebrates from 7-dehydrocholesterol exposed to UV B radiation from the sun. Vitamin D3 can also be obtained from certain dietary animal products and supplementation. Vitamin D2, also known as ergocalciferol, is introduced into humans primarily by commercial supplementation. It is produced by UV irradiation of ergosterol, a substance that occurs in yeast, molds and certain plants. Despite their distinct origins, both vitamin D2 and D3 share similar chemical structure, metabolic activation in humans, and presumably bioactivity as well, although the literature suggests that vitamin D2 is biologically inferior. Their structures differ only by a side chain, and the starting forms of both in humans, cholecalciferol and ergocalciferol, are hormonally inactive. Both undergo hydroxylation to 25hydroxyvitamin D(2 or 3) in the liver, followed by further conversion to the active hormone, 1,25dihydroxyvitamin D(2 or 3) in the kidney (or the placenta during pregnancy). 25-hydroxyvitamin D3 is also known as calcidiol, while the active form 1,25-dihydroxyvitamin D3 is also known as calcitriol. It is more difficult to find trivial name forms for the vitamin D2 group, although IUPAC recommends ercalcitriol for the active form of D2 (See nomenclature table). “Vitamin D” based Name Vitamin D2 Vitamin D3 25-Hydroxyvitamin D2 25-Hydroxyvitamin D3 1,25-dihydroxyvitamin D2 1,25-dihydroxyvitamin D3 Trivial Name ergocalciferol cholecalciferol -none foundcalcidiol ercalcitriol calcitriol Measurement of the vitamin D parent compound, whether D3 or D2, has limited clinical value because, with a half-life of about 1 day, the value reflects mostly recent sun exposure or intake (there may be a utility in assessing absorption from the gut). Vitamin D status is generally determined by measuring the intermediate 25-hydroxyvitamin D form, the major circulating form with a half-life of 2-3 weeks. Whether there is a value to distinguishing the relative contribution of 25-hydroxyvitamin D2 compared to D3 depends on the objective. Understanding vitamin D status generally requires a total number; however, the need to assess response to supplementation with vitamin D2, for example, may be helped with distinct reports on both forms. The active hormone, 1,25-dihydroxyvitamin D (2 or 3), has a short half- life of 4 – 6 hours, and its concentration is tightly regulated. This makes it a poor candidate for assessing nutritional vitamin D status, although its measurement has utility in differential diagnosis of hyper and hypocalcemia and bone and mineral disorders. An alternative metabolism pathway in the kidney yields a 24,25-dihydroxyvitamin D form. This is the most prevalent dihydroxylated metabolite in circulation, but (unlike the 1,25-dihydroxyvitamin D forms), it is not hormonally active. The physiological role of 24,25-dihydroxyvitamin D is unclear, although it 149 LOINC® Users’ Guide - June 2016 has been suggested that the active hormone may self-modulate by shunting toward this pathway. Specific Parts Vitamin D3 Vitamin D plays important roles in maintaining calcium and phosphate levels, and in immune regulation, but its determination is complex due to multiple metabolic intermediates and 2 major forms. Vitamin D3, also known as cholecalciferol, is the parent compound of one of the 2 major families of vitamin D (D2 and D3). Vitamin D3 is the form of vitamin D that is endogenously produced in the skin of vertebrates (including humans) upon exposure to sunlight (specifically UV B). It can also be obtained from dietary animal products, or dietary supplements. Vitamin D3, whether produced endogenously or ingested, is a prohormone form that is not active until further metabolism first to 25-hydroxyvitamin D3 (in the liver), then finally to 1,25-hydroxyvitamin D3 (in the kidney or placenta) . Measurement of the vitamin D parent compound, whether D3 or D2, has limited clinical value because, with a half-life of about 1 day, the value reflects mostly recent sun exposure or intake (there may be a utility in assessing absorption from the gut). Vitamin D status is generally determined by measuring the intermediate 25-hydroxyvitamin D form, the major circulating form with a half-life of 2-3 weeks. The need to assess response to supplementation with vitamin D2, for example, may be helped with distinct reports on both forms. Vitamin D2 Vitamin D plays important roles in maintaining calcium and phosphate levels, and in immune regulation, but its determination is complex due to multiple metabolic intermediates and 2 major forms. Vitamin D2, also known as ergocalciferol, is the parent compound of one of the 2 major families of vitamin D (D2 and D3). Vitamin D2 is the form of vitamin D that is not endogenously produced in the skin. It is produced upon UV radiation of ergosterol, which occurs in molds, yeast, and certain plants, and its major introduction into humans is via commercial supplementation. Vitamin D2 is a prohormone form that is not active until further metabolism first to 25-hydroxyvitamin D2 (in the liver), then finally to 1,25hydroxyvitamin D2 (in the kidney or placenta) . Measurement of the vitamin D parent compound, whether D3 or D2, has limited clinical value because, with a half-life of about 1 day, the value reflects mostly recent sun exposure or intake (there may be a utility in assessing absorption from the gut). Vitamin D status is generally determined by measuring the intermediate 25-hydroxyvitamin D form, the major circulating form with a half-life of 2-3 weeks. The need to assess response to supplementation with vitamin D2, for example, may be helped with distinct reports on both forms. 25-Hydroxyvitamin D, 25-Hydroxyvitamin D2, and 25-Hydroxyvitamin D3 The 25-hydroxyvitamin D intermediate is the major circulating metabolite of vitamin D with a half-life of 2-3 weeks, and it is the most useful measure of vitamin D status. The determination of vitamin D is complex due to multiple metabolic intermediates and 2 major forms, vitamin D2 and D3. The lack of specification of the form generally indicates that both are included. Vitamin D3 is the form of vitamin D that is endogenously produced in the skin of vertebrates (including humans) upon exposure to sunlight (specifically UV B), whereas vitamin D2 is produced upon UV radiation of ergosterol, which occurs in molds, yeast, and certain plants, and its major introduction into humans is via commercial supplementation, although both D3 and D2 can be included as supplements. The 25-hydroxyvitamin D metabolites of both forms (also known as calcidiol in the case of D3) are produced in the liver from the corresponding parent compound. Whether there is a value to distinguishing the relative contribution of 150 LOINC® Users’ Guide - June 2016 25-hydroxyvitamin D2 compared to D3 depends on the objective. Understanding vitamin D status generally requires a total number; however, the need to assess response to supplementation with vitamin D2, for example, and other specific cases, may be helped with a distinct reports on both forms. 1,25-Hydroxyvitamin D, 1, 25-Hydroxyvitamin D2, and 1, 25-Hydroxyvitamin D3 1,25-hydroxyvitamin D is the physiologically active form of vitamin D. When metabolically activated to this form, vitamin D plays important roles in maintaining calcium and phosphate levels, and in immune regulation. It increases intestinal absorption of calcium and phosphorus, and in concert with parathyroid hormone increases bone resorption. There are 2 major forms of vitamin D, each of which can be activated to a 1,25-dihydroxy form (also known as calcitriol in the case of D3 and ercalcitriol in the case of D2). Vitamin D3 is the form of vitamin D that is endogenously produced in the skin of vertebrates (including humans) upon exposure to sunlight (specifically UV B). It can also be obtained from dietary animal products, or dietary supplements. Vitamin D2 is the form of vitamin D that is not endogenously produced in the skin. It is produced upon UV radiation of ergosterol, which occurs in molds, yeast, and certain plants, and its major introduction into humans is via commercial supplementation. Vitamin D, whether produced endogenously or ingested, is a prohormone form that is not active until further metabolism first to 25 hydroxyvitamin D3 (in the liver), then finally to the active 1,25 hydroxyvitamin D3 (in the kidney or placenta). The active hormone, 1,25-dihydroxyvitamin D (2 or 3), has a short half-life of 4 – 6 hours, and its concentration is tightly regulated. This makes it a poor candidate for assessing nutritional vitamin D status, although its measurement has utility in differential diagnosis of hyper and hypocalcemia and bone and mineral disorders. 24,25-Dihydroxyvitamin D3 24,25-dihydroxyvitamin D3 is a compound which is closely related to 1,25-dihydroxyvitamin D3, the active form of vitamin D3, but (like vitamin D3 itself and 25-hydroxyvitamin D3) is inactive as a hormone. It is produced from 25-hydroxyvitamin D3 by alternative metabolic pathway in the kidney. The physiological role of 24,25-dihydroxyvitamin D is unclear, although it has been suggested that the active hormone may self-modulate by shunting toward this pathway. References: Houghton, L A, Vieth R. The case against ergocalciferol (vitamin D2) as a vitamin supplement. American Journal of Clinical Nutrition 2006; 84 (4):694-697. [PMID: 17023693] Morris, H A. Vitamin D: A Hormone for All Seasons - How much is enough? Understanding the New Pressures. Clinical Biochemist Reviews 2005; 26(1):21-32. [PMID: 16278774] St-Arnaugh, R, Glorieux, F H. 24, 25-Dihydroxyvitamin D—Active Metabolite or Inactive Catabolite? Endocrinology 1998;139:3371-3374. [PMID: 9681484] IUPAC-IUB Joint Commission on Biochemical Nomenclature (JCBN). Nomenclature of vitamin D. Recommendations 1981. Pure & Appl.Chem. 1982; 54(8): 1511—1516. Burtis, C A, Ashwood, E R. Tietz Textbook of Clinical Chemistry, 3rd ed.: Saunders; 1994. Wikipedia: http://en.wikipedia.org/wiki/Vitamin_D 151 LOINC® Users’ Guide - June 2016 Free Thyroxine Index Variants Author: David Baorto, MD, PhD Written: January 2012 Although direct measurement of the free hormones has recently become more prevalent, the older methods to estimate free hormone levels by deriving an index still persist. The index methods involve adjusting the total thyroid hormone concentration (TT4) for the thyroid binding capacity of the serum (T3 uptake or thyroid binding globulin TBG) to yield an indicator or estimate of the free hormone level, free thyroxine index (FTI). Over time and across labs this calculation has been and is done in different ways, yielding different results sometimes with different properties. This is mostly due to distinctions in what is known as “T uptake”. Here are some variations: 1) FTI = TT4(ug/ml) x T3 uptake (%)/100 • This has sometimes been noted leaving off the division by 100, but not in practice: FTI = TT4(ug/ml) x T3 uptake(%). 2) FTI = TT4(ug/ml) x (T3 uptake patient/T3 uptake control) (ratio) • Here, “T3 uptake” used in the calculation is actually the thyroid hormone binding ratio noted throughout the literature (THBR), the ratio of patient to reference serum values of T3 uptake. 3) FTI = TT4(ug/ml) / T uptake units (ratio) • Here “T uptake units” is ratio of patient to reference serum levels of thyroxine binding globulin (TBG). Notes: • In variation 1, the uptake is a %, while in variations 2 and 3 the uptake is a unit-less ratio normalized to control, known in the literature as the thyroid hormone binding ratio (THBR). • Variation 1 is apparently the reporting approach used by Mayo, ARUP, and LabCorp and many hospital labs (such as one large NY hospital). It adjusts the total T4 by a T3 uptake % (approximate range 25-40%), and yields FTI values often in the approximate range of 1 to 5 (adults) and is reported as unit-less. • Variation 2 is apparently the reporting approach used by Quest Diagnostics-Nichols and some hospital labs (such as another large NY hospital), and variation 3 apparently the primary method used by Abbott Axsym (although values can be converted). • Variations 2 and 3 both adjust the total T4 (TT4) by a ratio referenced to a control value of 1, so FTI numerically is in the approximate range of TT4 concentration 5 – 12 (adults). While it is usually reported as unit-less, there is a case that it is really an adjusted TT4 concentration, and in fact the Abbott AxSym package insert (variation 3 above) notes units of ug/dl for its calculated FTI value. • THBR is a normalized T3 uptake which represents how much labeled T3 did NOT find a binding site in patient serum, meaning it is the INVERSE of available binding sites. Conversely, in the AxSYM method “T uptake units” is a control normalized ratio of TBG, a measure proportional to the binding sites. This may account for why one MULTIPLIES and the other DIVIDES by the 152 LOINC® Users’ Guide - June 2016 • ratio. The TBG is not the only thyroid hormone binding protein, another distinction between 2 and 3. Historically T3 instead of T4 has been more commonly used as the tracer in uptake assays for practical reasons. T3 has a lower affinity for TBG, so more would be available to be taken up by the scavenger and easier to count. With non-isotopic techniques, this may be less of an issue, and it has been suggested that T4 uptake would be more appropriate to adjust TT4 concentration. T4 uptake assays do exist. 153 LOINC® Users’ Guide - June 2016 Appendix H - LOINC Committee Members Name Organization Location Ray Aller John Baenziger Suzanne Bakken Pam Banning James Barthel Dean Bidgood Bruce Bray James Campbell Jim Case Jim Cimino Lorie Carey Robert Dolin James K Fleming Arden Forrey Bill Francis Pavla Frazier Bruce Goldberg Alan Golichowski Barry Gordon Brian Griffin Gil Hill Stan Huff Cindy Johns William (Bill) Karitis Ted Klein Jeff Lamothe Lee Min Lau Diane Leland Pat Maloney Doug Martin Susan Matney Ken McCaslin Clem McDonald University Southern California Pathology Indiana University Hospital Columbia School of Nursing 3M H. Lee Moffitt Cancer Center Duke Medical Center University of Utah University of Nebraska California Veterinary Diag Labs Columbia Presbyterian Med Center Canada Health Infoway Mayo Foundation Laboratory Corp of America University of Washington Augilent Technologies University of Utah Kaiser Permanente Indiana Univ. Dept. of Medicine C/NET Solutions Quest Diagnostics Hospital for Sick Children Intermountain Health Care LabCorp Department of Defense, U.S. Navy Klein Consulting, Inc USAF 3M HIS Riley Hospital for Children Quest Diagnostics Regenstrief Institute/IUSOM 3M HIS Quest Diagnostics NLM Lister Hill National Center for Biomedical Communications Regenstrief Institute National Medical Services Association Vanderbilt University Centers for Disease Control Oregon Health Sciences University Parners Healthcare, Inc. Instituto Tecnologie Biomediche Mayo Medical Laboratories Clinical Architecture World Health Organization CDC Eli Lilly & Co. University Hospital Health Patterns, LLC Regenstrief Institute/IUSOM ARUP Laboratories New York State Office of Mental Health CDC 3M HIS Vista, CA Indianapolis, IN New York, NY West Linn, OR Tampa, FL Durham, NC Salt Lake City, UT Omaha, NE Davis, CA New York, NY Saskatoon, SK, Canada Rochester, MN Burlington, NC Seattle, WA Andover, MA Salt Lake City, UT Pasadena,CA Indianapolis, IN Berkeley, CA Rutherford, NJ Toronto, ON, Canada Salt Lake City, UT Burlington, NC Onley, MD Ridge, NY Biloxi, MS Salt Lake City, UT Indianapolis, IN Teterboro, NJ Indianapolis, IN Salt Lake City, UT Collegeville, PA Bethesda, MD Kathy Mercer Deirdre O’Neill Judy Ozbolt Dan Pollock Rick Press Christine Raine Angelo Rossi Mori Jon Rosenblatt Shaun Shakib John Stelling Steve Steindel Jeff Suico Anders Thurin Wayne Tracy Daniel Vreeman Larry West Thomas White Warren Williams Pat Wilson 154 Indianapolis, IN Willow Grove, PA Nashville, TN Atlanta, GA Portland, OR Brookline, MA Rome, Italy Rochester, MN Salt Lake City, UT Geneva, Switzerland Atlanta, GA Indianapolis, IN Linkoping, Sweden Overland Park, KS Indianapolis, IN Salt Lake City, UT New York, NY Atlanta, GA Salt Lake City, UT Annex - RadLex-LOINC Radiology Playbook User Guide Welcome to the RadLex-LOINC Radiology Playbook User Guide. This work is the result of a multi-year collaboration between Regenstrief Institute and the Radiological Society of North America (RSNA), supported by the National Institute of Biomedical Imaging and Bioengineering (NIBIB). The participants have developed a model that combines and unifies the useful aspects of LOINC Radiology and the RSNA RadLex Playbook. Both of these terminology initiatives are designed to represent concepts of radiology orderables and results and their attributes. Each term in the unified Playbook model has a name (a.k.a. description), and takes on a number of attributes. This guide is intended to describe the semantics, syntax, and proper usage of those attributes. Within the terminology, these attributes are used as building blocks to construct several types of standard names, including a fully specified name, long name, and short name. A list of the Playbook attributes is shown below. Attributes are organized according to attribute groups, consisting of the major bullet headings below, and by more specific sub-attributes, shown in the minor bullets below and denoted by a dot after the attribute group, such as Pharmaceutical.Route. • • • • • • • Modality o Modality.Subtype Anatomic Location o Anatomic Location.Region Imaged o Anatomic Location.Imaging Focus o Anatomic Location.Laterality.Presence o Anatomic Location.Laterality View o View.Aggregation o View.View type o View.View type.Maneuver Pharmaceutical o Pharmaceutical.Substance Given o Pharmaceutical.Route o Pharmaceutical.Timing Reason for Exam Guidance o Guidance for.Presence o Guidance for.Approach o Guidance for.Action o Guidance for.Object Subject The chapters that follow provide a guide to the usage of each of the above attributes. 1 RadLex-LOINC Harmonized User Guide June 28, 2016 Codes and workflows Radiology procedure codes impact a variety of workflows in the health care enterprise, including ordering, scheduling, billing, protocol specification, image acquisition, and image interpretation, among others. In each case, the codes serve specific purposes in identifying imaging exams. While there is a great deal of overlap between these workflows, there are also important differences. For example, radiology billing is often concerned with a less detailed description of an imaging exam, while the radiology ordering process often involves more information about the requested study. The Playbook work has been primarily focused on addressing the needs of the radiology ordering workflow. The semantic model described in this document is intended principally to characterize radiology “orderables.” This then raises the question of what constitutes an orderable exam, an issue which is complicated by at least two factors. First, different institutions may expose different levels of granularity at the point of radiology order entry. While one may consider “CT abdomen / pelvis with contrast” to be an appropriate option in an order entry system, another institution may wish to provide the choice “CT abdomen / pelvis with contrast, liver mass.” Second, in certain circumstances, what is actually done to satisfy an imaging request may not match the ordered procedure precisely. For example, image-guided interventions often entail procedural modifications at the time of the exam. In such cases, modified or additional orderables may be entered, even though these may not have been exposed in the clinical ordering interface. The model aims to allow for this type of variation, so as to broadly fulfill the needs of radiology ordering workflows at a variety of institutions. Note that related work, at a more granular level addressing the technical factors in image acquisition, is being done by the DICOM Standards Committee [1]. 2 RadLex-LOINC Harmonized User Guide June 28, 2016 1 CONTENTS 2 SYNTAX............................................................................................................................ 5 2.1 OPERATORS ...................................................................................................................................................5 2.1.1 2.1.2 2.1.3 2.1.4 2.1.5 2.1.6 2.2 3 4 “.” ............................................................................................................................................................................. 5 “+” ............................................................................................................................................................................ 5 “>” ............................................................................................................................................................................ 5 “&”............................................................................................................................................................................ 5 “&or” ........................................................................................................................................................................ 5 Precedence .............................................................................................................................................................. 5 PARALLELISM.................................................................................................................................................5 MODALITY .............................................................................................................................................. 6 3.1 DEFINITIONS ..................................................................................................................................................6 3.2 USAGE NOTES................................................................................................................................................6 3.3 ALLOWED MODALITY/SUBTYPE COMBINATIONS ..............................................................................................7 ANATOMIC LOCATION ............................................................................................................................. 9 4.1 DEFINITIONS ..................................................................................................................................................9 4.2 SYNTAX AND MODELING PRINCIPLES ............................................................................................................ 10 4.2.1 4.2.2 4.2.3 4.2.4 4.2.5 4.2.6 4.2.7 4.2.8 4.2.9 4.2.10 4.2.11 4.2.12 4.2.13 4.2.14 5 6 Specifying region(s) imaged without an imaging focus..................................................................................... 10 Imaging foci that cross body regions .................................................................................................................. 10 Specifying multiple anatomic locations .............................................................................................................. 10 Broad region combined with a specific focus...................................................................................................... 11 Specifying terms without an anatomic location ................................................................................................ 11 Operator precedence ............................................................................................................................................ 11 Parallelism ............................................................................................................................................................. 11 Region imaged as grouper +/- coarse-grained descriptor .................................................................................. 11 Laterality ............................................................................................................................................................... 12 Subject .............................................................................................................................................................. 12 Ectopic Anatomy .............................................................................................................................................. 12 Anatomic terminology in the extremities ...................................................................................................... 12 Singular vs. Plural ............................................................................................................................................ 13 Singular vs. Plural in the context of Vasculature ........................................................................................... 13 VIEW .................................................................................................................................................... 14 5.1 DEFINITIONS ................................................................................................................................................ 14 5.2 USAGE NOTES.............................................................................................................................................. 14 5.3 EXAMPLES ................................................................................................................................................... 15 PHARMACEUTICAL ................................................................................................................................ 17 6.1 DEFINITIONS ................................................................................................................................................ 17 6.2 SYNTAX ....................................................................................................................................................... 17 6.3 EXAMPLES ................................................................................................................................................... 17 6.4 SPECIFYING MORE THAN ONE PHARMACEUTICAL ............................................................................................ 17 3 RadLex-LOINC Harmonized User Guide June 28, 2016 6.5 USAGE NOTES.............................................................................................................................................. 18 6.5.1 6.5.2 6.5.3 6.5.4 6.5.5 6.6 Preference for Generic Names ............................................................................................................................. 18 Route...................................................................................................................................................................... 18 Intra versus Via ...................................................................................................................................................... 18 Existence versus Absence .................................................................................................................................... 18 Relationship to View.Maneuver sub-attribute ................................................................................................... 18 ISSUES ......................................................................................................................................................... 19 REASON FOR EXAM .............................................................................................................................. 20 7 7.1 DEFINITIONS ................................................................................................................................................ 20 7.2 EXAMPLES ................................................................................................................................................... 21 7.3 NOTES ......................................................................................................................................................... 21 8 GUIDANCE ............................................................................................................................................ 22 8.1 DEFINITIONS ................................................................................................................................................ 22 8.2 USAGE NOTES.............................................................................................................................................. 22 8.2.1 8.2.2 8.2.3 8.2.4 8.2.5 8.3 9 Guidance for.Approach......................................................................................................................................... 22 Guidance for.Action .............................................................................................................................................. 22 Anatomic Location and Guidance for.Object ..................................................................................................... 23 Modality attribute................................................................................................................................................. 23 Specifying more than one procedure .................................................................................................................. 23 EXAMPLES ................................................................................................................................................... 24 SUBJECT ............................................................................................................................................... 25 9.1 10 DEFINITIONS ................................................................................................................................................ 25 REFERENCES..................................................................................................................................... 26 4 RadLex-LOINC Harmonized User Guide June 28, 2016 2 SYNTAX 2.1 OPERATORS The model uses several logical operators (“.”, “+”, “>”, “&”, “&or”) to express combinations of atoms. 2.1.1 “.” Used to specify refinement of a given attribute or attribute component. For example, the dot operator may be used with the View type component of the View attribute to specify a Maneuver sub-component (e.g. “lateral.flexion”). For modality subtypes, it is used to indicate a certain type of imaging technique (e.g. “CT.angio”). 2.1.2 “+” Used to combine atoms, such as Anatomy atoms or View atoms, with AND semantics. 2.1.3 “>” Used exclusively to separate the body region from the anatomic imaging focus. 2.1.4 “&” Used to separate atoms for parallelism, such as in Anatomy or View. May alternatively be used as a low-precedence AND, such as in the Pharmaceutical.Timing attribute WO&W, which has a combined “before and after” notation. This is the lowest-precedence of all the operators in the model. 2.1.5 “&or” Used to join two atoms via logical (inclusive) disjunction. For example, fine needle aspiration &or core needle biopsy means that either or both procedures were done. 2.1.6 Precedence Operator precedence, from greatest to least is as follows: “.”, “+”, “>”, “&”, “&or” 2.2 PARALLELISM In selected circumstances, it is necessary to specify multiple values for two or more specific attributes or components. In such cases, the correspondences between values across attributes or components may be modeled by maintaining a consistent ordering of values. For example, a radiographic exam of the ribs often includes a radiograph of the chest. The specific views may include an AP view of the chest, and an oblique view of the ribs. Multiplicity of the Anatomic Location attribute as well as the View attribute is modeled using parallelism and the “&” operator. That is, with Anatomic Location “Chest & Ribs” and View “AP & Oblique” the appropriate correspondence between “Chest” and “AP” as well as between “Ribs” and “Oblique” is maintained by virtue of the relative positions of the atoms (i.e. both “Chest” and “AP” are listed first in their respective attributes). 5 RadLex-LOINC Harmonized User Guide June 28, 2016 3 MODALITY 3.1 DEFINITIONS Modality is used to represent the device used to acquire imaging information. Modalities consist predominantly of a subset of the two-letter DICOM modality codes. DICOM modality codes are listed in PS3.3, Section C.7.3.1.1.1 in the 2016 release of the DICOM standard [2]. In addition, the modality code “RP” is used to indicate image-guided procedures for which the specific type of imaging is not explicitly modeled. A Modality subtype may be listed, separated by a “.”, to signify a particularly common or evocative configuration of the modality. Note that when such modality subtypes are specified, the given type of technique is included in a study, although this does not necessarily imply that the study consists exclusively of that subtype of imaging. For example, an exam with modality and subtype US.doppler does not mean than only Doppler imaging was performed. On the other hand, XR.portable generally does indicate that only portable images were obtained. 3.2 USAGE NOTES 1. Subtype angio. This subtype is used for procedures designed to give angiographic images of the vessels. This should not be used for US; Doppler should be used instead. Angio is not a synonym for contrast administration because some angiographic MR studies do not require intravenous contrast administration. 2. Subtype full field digital and analog for MG. MG.analog indicates an analog mammogram. MG.full field digital signifies a digital mammogram only. MG without a subtype signifies a procedure that can be done with digital or analog equipment. 3. CR (computed radiography) vs DX (digital radiography) vs RG (radiographic imaging/conventional film screen): XR will be adopted generically to signify orders for planar radiography. When the images are acquired, the imaging modality may wish to insert a more specific modality code in the DICOM files. 4. Doppler subtype vs DICOM modality codes DD (duplex Doppler) and CD (color flow Doppler). US.Doppler will be used as the attribute of the orderable procedure. When the images are acquired, the imaging modality may wish to insert a more specific modality code in the DICOM files. 5. Portable indicates whether the device is movable or whether the patient will come to the radiology department for imaging. 6. The SPECT modality will be represented as a subtype of the NM modality (NM.SPECT) rather than using ST, the DICOM modality code for SPECT. 7. Because there is no DICOM modality code for DEXA, DXA will be adopted as the modality code. 8. When an imaging study involves more than one imaging modality, “+” is used to concatenate the two modalities, such as “PT+CT” or “NM.SPECT+CT”. The modality listed first corresponds to the departmental area where the device is typically located. E.g. PT+CT, not CT+PT 6 RadLex-LOINC Harmonized User Guide June 28, 2016 9. For studies with two modalities that have separate attributes and are performed consecutively (e.g., RF Upper GI with XR abdomen), “&” is used in the value of each attribute, including Modality, to maintain parallelism across attributes. 10. Precedence of operators is “.”, “+”, “&” (“>” is not used in the Modality attribute) 11. The perfusion modality subtype indicates the study is intended to measure tissue perfusion; if the study is designed to image the vessels, use the angio modality subtype. 12. 3D is an image processing step, and can be performed on images from a variety of modalities. Its use is discouraged. If adopted locally, it may be used as shown in the Chapter on Reason for Exam. 13. Modality RP (radiology procedure) is used to refer to image-guided procedures, where the particular type of imaging used is not specified in the orderable. For example, liver biopsies may be performed under ultrasound or CT guidance, although the particular modality used may be at the discretion of the operator. In such cases, RP indicates image guidance not further specified. 3.3 ALLOWED MODALITY/SUBTYPE COMBINATIONS • • • • • • • • CT o o o o o DXA o MG o o o o MR o o o NM o o PT o RF o o o US o CT.angio CT.scanogram CT.densitometry CT.perfusion CT.portable DXA.densitometry MG.full field digital MG.analog MG.tomosynthesis MG.stereotactic MR.angio MR.functional MR.spectroscopy NM.dosimetry NM.SPECT PT.perfusion RF.angio RF.video RF.portable US.densitometry 7 RadLex-LOINC Harmonized User Guide June 28, 2016 • • o o US.Doppler US.portable o o XR.tomography XR.portable XR RP 8 RadLex-LOINC Harmonized User Guide June 28, 2016 4 ANATOMIC LOCATION This chapter describes how anatomic terms are used to identify the body region and anatomic focus of imaging. It also specifies the syntax to be used when more than one anatomy term applies to a given exam code, and delineates how laterality should be specified when necessary. Please note: as of the June 2016 LOINC release (v2.56), most of the Region imaged and Imaging focus values have been specified in the LOINC System part (which corresponds to the Playbook Anatomic Location attribute) according to the syntax described below with two major exceptions. First, the Upper Extremity and Lower Extremity Regions imaged have not yet been explicitly modeled for most of the extremity terms that have a specific Imaging focus. Second, the syntax for specifying multiple Anatomic Locations as described in Section 4.2.3 and 4.2.4 is not yet implemented. We anticipate that both of these exceptions will be addressed in the December 2016 LOINC release. 4.1 DEFINITIONS The Anatomic Location attribute specifies the body part or body region that is imaged and includes the sub-attributes, Region imaged and Imaging focus. The most specific anatomic structure should be specified. Multiple Anatomic Locations may be specified using the syntax specified below and should be specified only when necessary to distinguish the code from other codes. Anatomic Location terms are generally drawn from the RadLex anatomic hierarchy. Region imaged is used in two ways. First, as a coarse-grained descriptor of the area imaged and a grouper for finding related imaging exams. Or it is used just as a grouper. For example, when an abdominal CT focuses on the liver, it images the abdomen as a whole and also would be a relevant comparison for other abdominal CT exams (e.g. renal CT), thus making abdomen a coarse-grained descriptor as well as a grouper. Similarly, a head CT focusing on the brain may also be a relevant comparison for other head CT exams (e.g. orbit CT), making it both a descriptor and grouper. Alternatively, for most studies with upper extremity or lower extremity as the Region imaged and a specific Imaging focus, such as wrist or knee, the Region imaged is a grouper only, because the entire extremity is typically not imaged. Imaging focus is defined as a more fine-grained descriptor of the specific target structure of an imaging exam. In many areas, the focus should be a specific organ. For example, in the Region imaged abdomen, the Imaging focus might be liver, pancreas, adrenal glands, kidneys, etc. In other areas, the Imaging focus will simply be a more specific area within a given region. For example, in the Region imaged upper extremity, the Imaging focus might be shoulder, upper arm, elbow, forearm, wrist, hand, etc. Our goals are to populate both the Region imaged and Imaging focus sub-attributes for all terms, except where the Region imaged is the focus of the study (see 4.2.1). We will also constrain Region imaged to the following short list of regions: head, neck, chest, breast, abdomen, pelvis, upper extremity, lower extremity. 9 RadLex-LOINC Harmonized User Guide June 28, 2016 Exceptions to the short list of Regions imaged include cases in which the Imaging focus exists throughout the body and is being imaged in its entirety, such as bones or bone marrow. In these cases, the Region imaged is whole body, e.g. Whole body>Bone marrow. In contrast, when the Imaging focus exists in multiple parts of the body but only one specific instance is being imaged, the Region imaged is unspecified, which is given as “XXX” in LOINC, e.g. XXX>Bone. Pathologic entities may not serve as an anatomic location (e.g. renal tumor). If there is a need to specify a pathologic entity to distinguish to exam codes, the pathologic entity should be specified with the Reason for Exam attribute or Guidance for.Object sub-attribute. 4.2 SYNTAX AND MODELING PRINCIPLES The syntax used to describe the Anatomic Location attribute is as follows: <body region imaged> “>” <imaging focus> For example, for an abdominal CT with a focus on the liver, the Anatomic Location would be specified as: Abdomen>Liver As noted in the introduction to this chapter, the June 2016 LOINC release does not reflect this syntax for most of the existing terms that would be expected to have Upper extremity or Lower extremity as the Region imaged. For example, the Anatomic Location for wrist is still represented as Wrist rather than Upper extremity>Wrist. 4.2.1 Specifying region(s) imaged without an imaging focus If there is a single anatomic context associated with a code, it should be specified as <body region imaged> without an <imaging focus>, for example, for an abdominal CT, the Anatomic Location would be specified as: Abdomen When multiple regions are imaged without an imaging focus, such as CT of the head and neck, the two regions are separated by a “+”: Head+Neck 4.2.2 Imaging foci that cross body regions Certain imaging foci cross multiple body regions, such as Pharynx, which is included in both the Head and Neck imaging regions. In this case, the regions will be separated by a “+” as follows: Head+Neck>Pharynx 4.2.3 Specifying multiple anatomic locations When more than one anatomic location is imaged, where each location has a different Region imaged and Imaging focus pair, they are separated by an “&” according to the syntax: <body region imaged A> “>” <imaging focus A> “&” <body region imaged B> “>” <imaging focus B> 10 RadLex-LOINC Harmonized User Guide June 28, 2016 For example, a study of the chest and abdomen focused on the lung and liver would be specified as follows: Chest>Lung & Abdomen>Liver Note – this is a change from the previous version of Playbook and will be implemented in LOINC starting with the December 2016 release. The June 2016 release contains terms modeled according to the previous model, where multiple locations were specified by grouping the Regions imaged together, separated by a “+”, and grouping the Imaging foci together, also separated by a “+”, with the Regions imaged and Imaging foci groups separated by “>”. So the example above in the previous model (and current LOINC release) is specified as: Chest+Abdomen>Lung+Liver 4.2.4 Broad region combined with a specific focus In other situations, a specific Imaging focus in one Region imaged may be imaged at the same time as a different Region imaged without a focus. Consider an MRI examination of the face and neck. Face is an Imaging focus of the Region imaged head. Neck is an additional Region imaged. In such situations, the lower precedence of the “&” compared to the “>” operator is used to combine these areas as follows: Head>Face & Neck 4.2.5 Specifying terms without an anatomic location In some cases, such as fluoroscopic guidance codes, a specific Anatomic Location may not be relevant, in which case we use the general unspecified Region imaged. 4.2.6 Operator precedence The precedence of operators is “.”, “+”,“>”,”&”. For example: Head+Neck > Pharynx is equivalent to (Head+Neck)> Pharynx 4.2.7 Parallelism In rare instances, a complex study may require parallelism to model correctly. In this instance, an ampersand is used to separate the elements of the study. For example, a study that consists of a PA and lateral views of the chest plus 4 oblique views of the right ribs could be represented as follows: XR Chest&Ribs.Right 2 views & 4 views including PA+Lateral & Right oblique 4.2.8 Region imaged as grouper +/- coarse-grained descriptor The nature of the study should make it clear whether the Region imaged is functioning as both a coarsegrained descriptor of the area imaged and a grouper or as a grouper only. Following are additional guidelines to help users make that determination: 11 RadLex-LOINC Harmonized User Guide June 28, 2016 1. In general, when the Region imaged is the head, neck, chest, abdomen or pelvis, it is both a coarsegrained descriptor and a grouper; 2. For spine studies, the Region imaged is typically a grouper only (this is an exception to rule #1). For example, a C-spine exam will have the Anatomic location specified as Neck>Spine.cervical, but typically the exam would focus on the spine and not include general imaging of the neck; 3. When the Region imaged is upper extremity or lower extremity, it typically functions as a grouper only. 4.2.9 Laterality Many exams require laterality to be specified in order to be performed. These exams will be signified with an Anatomic Location.Laterality.Presence attribute set to True. For terms with Laterality.Presence = True, the Laterality attribute must not be null. Valid values of the Laterality attribute are: • Left • Right • Bilateral • Unilateral • Unspecified The recommended practice is to specify one of Left, Right, or Bilateral for Anatomic Location.Laterality whenever Anatomic Location.Laterality.Presence = True. If the Laterality.Presence attribute is False, the Laterality attribute must be null. Laterality applies to the most specific anatomic part associated with the exam code. 4.2.10 Subject Some exams are relevant only to a Fetus or a Gestation. This distinction will be represented when necessary by the Subject attribute. 4.2.11 Ectopic Anatomy Ectopic anatomy, such as a transplanted kidney, if needed to distinguish an exam code, should be specified as a Reason for Exam, not as an Anatomic Location. Anatomic Location corresponds to where the transplanted kidney is located, e.g., Pelvis. 4.2.12 Anatomic terminology in the extremities In the upper extremity, the term “upper arm” is preferred over the term “arm.” Even though these are technically equivalent, the redundancy of “upper arm” provides for greater clarity. “Upper arm” is also preferred over “humerus” for this area, as the latter is bone-specific and could be construed as excluding soft tissues. Similarly, in the lower extremity, “lower leg” is preferred over “leg,” “calf” and “tibia / fibula.” 12 RadLex-LOINC Harmonized User Guide June 28, 2016 4.2.13 Singular vs. Plural The singular form of an anatomic structure is typically used, except in a few specific cases that primarily apply to vasculature, as noted below. 4.2.14 Singular vs. Plural in the context of Vasculature For the set of vessels associated with a particular region, organ or a specific group of vessels, we use the plural “Vessels”, “Veins” and “Arteries” to mean “set of”, for example, “Adrenal vessels” or “Cerebral arteries.” One use case for such pre-coordination is angiography, for example, CT angiography of the renal vessels would have the following Anatomic location: Abdomen >Renal vessels The plural form does not imply laterality, which is still specified using the laterality attribute (see 4.1.10). For example, “Abdomen>Renal vessels.right” means the set of renal vessels supplying the right kidney. Specific named vessels use the singular form, e.g., “Femoral vein” and “Superior mesenteric artery.” When vessels in an extremity are imaged for a specific reason, such as varicose vein treatment, and there are different CPT codes for treatment of a single vessel and treatment of multiple vessels, we use the plural form to mean multiple and also created a singular form to represent treatment of a single vessel even though that vessel is not named, i.e., “extremity veins” and “extremity vein.” 13 RadLex-LOINC Harmonized User Guide June 28, 2016 5 VIEW 5.1 DEFINITIONS The View attribute is used to indicate the orientation of the patient in the image. This may reflect a combination of patient position and x-ray beam direction, or may alternatively be captured in a named, or eponymous, view. While this most commonly refers to radiography (e.g. a lateral radiograph of the chest), it may also be used with other modalities (e.g. prone CT of the chest). In many instances, the View attribute will not be specified at all (e.g. MRI of the brain) in the Playbook model. However, note that in the LOINC model, the Component part of all radiology terms specifies the type of image acquired based on the modality: “Views” for XR, MAM, and NM, and “Multisection” for MR, CT, US, NM.SPECT, PT, and XR.tomography. When View is specified in Playbook, three optional components may be used: <Aggregation> <View type>.<Manuever> The Aggregation component is used to describe the extent of the imaging performed, whether in quantitative terms (e.g. “3 or more views”) or subjective terms (e.g. “complete”). The use of “Followup” as a value of the aggregation attribute is replaced by the value “Limited.” View type is used to name specific views, such as “lateral” or “prone.” View type may optionally have an additional Maneuver sub-component. Maneuver is used to indicate an action taken with the goal of elucidating or testing a dynamic aspect of the anatomy. For example, flexion and extension views of the cervical spine are used to detect instability as indicated by changes in spinal alignment. Similarly, inspiratory and expiratory views of the chest may be used to detect changes in lung volume. Maneuvers imply an element of patient exertion, and may occur in pairs (e.g. “flexion” and “extension”). These factors distinguish maneuvers from patient actions used purely to gain a desired perspective. For example, the cross-table lateral radiograph of the hip requires the patient to be lying supine with the contralateral leg bent and raised, though the purpose of this is to obtain a lateral angle on the hip rather than to test stability or dynamic change. In such cases, the patient position is embodied in the named view type (e.g. “Danelius Miller”) rather than with a maneuver. 5.2 USAGE NOTES 1. Views may be aggregated in groups. Sometimes these groups may be further specified by naming specific views (e.g. “PA + lateral”), in which case the semantics are that the group includes the named views. In some cases the views are specified numerically (e.g. “4 views”). Other times the constituent views of a group may be unspecified (e.g. “complete”). 2. The naming of specific views is optional. 3. The use of an aggregation term is optional. 4. Eponymous views imply patient position and beam direction, as well as anatomic focus. Anatomic focus will continue to be specified separately as described above, recognizing this redundancy. 14 RadLex-LOINC Harmonized User Guide June 28, 2016 5. Maneuvers may be specified on a per-view basis (e.g. “Lateral.flexion + Lateral.extension”). 6. If no maneuver is specified, it is assumed that the patient is at rest. 7. Laterality may optionally be specified in certain views (e.g. “Lateral,” “Right lateral” or “Left lateral”). The laterality specified in this case indicates patient position relative to the beam, not the side of the patient being imaged, and is thus independent of the Anatomic Location.Laterality sub-attribute. 8. Portable is specified as a Modality subtype instead of a View. 9. The large majority of exams will have no view specified at all. In the RSNA Core Playbook, 29 exams use views out of 1031 exams, and all of these are XR exams. 10. When the number of views is specified for a bilateral exam, the number refers to the number of views per side (e.g., XR Knee Bilateral 2 Views specifies 2 views of each knee) 11. Time-related factors, such as “48 hours post”, are modeled with the Pharmaceutical attribute. 12. Sometimes, parallelism is required to show which attributes are associated with which views. The ampersand is used to show parallelism. For example, a combined exam with chest and rib views would be modeled as: XR Chest&Ribs.Right 2 views & 4 views including PA+Lateral & Right oblique That is, the atoms “Chest” “2 views” and “PA+Lateral” form one group, and the atoms “Ribs.Right” “4 views” and “Right oblique” form another group. Note that this parallelism relies on a consistent ordering of atoms to maintain proper groupings. 13. If the views for the second anatomic location are unspecified, the unspecified views will be modeled as “XXX”. For example: XR&RF Chest&Diaphragm 2 views & XXX XR&RF Abdomen&UGI Tract 1 view & XXX 5.3 EXAMPLES <View(s)> XR Chest PA XR Chest L decubitus CT Chest CT Chest Supine XR Hand, bilateral Ball catcher XR Abdomen AP <Aggregation> including <View(s)> XR Chest 2 views {PA + Lateral} XR Ankle Complete XR Shoulder 3 views {Axillary} XR Hip 2 views {Cross table lateral} 15 RadLex-LOINC Harmonized User Guide June 28, 2016 XR C-spine 4 views {Right oblique + Left oblique} XR Abdomen 2 views {Supine + Upright} XR C-spine 4 views {Lateral.flexion + Lateral.extension} XR Foot 3 views {Lateral.weight-bearing} XR Knee.Bilat 4 views {Right oblique + Left oblique} CT Chest 2 views {Supine.inspiration + Supine.expiration} CT Colon 2 views {Supine + Prone} 16 RadLex-LOINC Harmonized User Guide June 28, 2016 6 PHARMACEUTICAL 6.1 DEFINITIONS The Pharmaceutical attribute specifies the presence or absence of chemical agents relevant to the imaging procedure. We use this attribute to specify administered contrast agents, radiopharmaceuticals, medications, or other clinically important agents and challenges during the imaging procedure. 6.2 SYNTAX The syntax used to describe the Pharmaceutical attribute specifies several optional components: <timing/existence><substance given><route> Only the components required for specifying the pharmaceutical at a clinically important level are included in the attribute value. The <timing/existence> attribute can be either simultaneous: • • WO W A combined “before and after” notation that denotes separate sets of images: • WO & W Or describing an image taken at a specified time after administration of the pharmaceutical: • 48H post 6.3 EXAMPLES Using this syntax, a common contrast specification of without then with IV contrast would be denoted: WO & W contrast IV In other cases, the time delay is a key component: 48H post contrast PO 6.4 SPECIFYING MORE THAN ONE PHARMACEUTICAL The syntax above can also be used to specify more than one pharmaceutical that may be influence the imaged physiology. For example, a nuclear medicine cardiac stress test may involve administration of a radiopharmaceutical and a stress agent such as Adenosine, Dobutamine, or Regadenoson. The attribute value list will contain only single pharmaceuticals. We specify multiple instances of the pharmaceutical attribute by combining them with “+”: W adenosine + W radionuclide IV 17 RadLex-LOINC Harmonized User Guide June 28, 2016 W dipyridamole + W Tc-99m Sestamibi 6.5 USAGE NOTES Some pharmaceuticals will be more fully specified than others. For example, some may specify the specific substance: W Tc-99m Sestamibi IV whereas others name a more generic class: W radionuclide IV W anesthesia 6.5.1 Preference for Generic Names We use the generic name of a pharmaceutical, not the brand name, e.g. Tc-99m Sestamibi, not Cardiolite. We will usually include the brand or trade names as synonyms. In rare cases, we use the brand name when a generic form does not exist (e.g., Theraspheres). 6.5.2 Route Where possible, we denote the route of administration by abbreviations for medication routes (Table 6 of the LOINC Users’ Guide). An oral route of administration would be denoted by “PO,” an intravenous route by “IV.” 6.5.3 Intra versus Via When describing administration of contrast into specific spaces for which abbreviations do not exist, the space is spelled out in full, and preceded by “intra” or “via” according to these guidelines. We use “intra” when the contrast injected goes directly into this anatomic space, and this space is what is visualized in the study. For example: W contrast intra lymphatic We use “via” when the contrast injected goes through this device (e.g., catheter) and into the anatomic space being visualized. For example: W contrast via colostomy 6.5.4 Existence versus Absence The <existence> component of the pharmaceutical attribute allows specification of whether or not the imaging occurs in the presence of the agent where existence is denoted W, WO, or WO & W. The existence of WO & W denotes separate images, without and with the pharmaceutical. 6.5.5 Relationship to View.Maneuver sub-attribute Like the physical maneuvers described in the chapter on the View attribute, pharmaceutical agents are also intended to test a dynamic aspect of the anatomy, with similarities in how these are modeled. In some cases, an exam may use one or the other that are intended to produce a similar anatomic response (e.g., W exercise or W adenosine). Where needed, they can also be used together as different 18 RadLex-LOINC Harmonized User Guide June 28, 2016 attributes of the overall term model. For example, in defecography, both a maneuver and contrast are specified: W contrast PR & during defecation 6.6 ISSUES • • • • • • • • [Decision: YES] LOINC to change order (WO then W) pattern [Decision: NO] Should the existence convention be changed to the more redundant but more clear full expression: o WO contrast IV & W contrast IV [Decision: No] Should the combination pharmaceuticals be items in the attribute value list? Is there a more up to date specification of Routes? Not really. FHIR uses this same table. Some were added in 2.3.1 [Decision: YES] Should we remove the amount sub-attribute? Intra articular -> IS (Intrasynovial) We will use quotes for keeping together separate words within an attribute. We’ll look for naming conventions to eliminate the need for this. We will convert WO & W to WO&W. Include the Modifiers from Views: o Deprecate usage of “1 phase” in LOINC (it is implied unless stated as 3 phase) o 3 Phase o 30M post o 45M post o Delayed o Runoff 19 RadLex-LOINC Harmonized User Guide June 28, 2016 7 REASON FOR EXAM 7.1 DEFINITIONS Reason for exam is used to describe a clinical indication or a purpose for the study. This may refer to a patient diagnosis, a clinical indication, a clinical status (e.g. “post op”), an intended measurement, altered anatomy (e.g. “endograft”), or some other indicator of the purpose of the exam (e.g. “screening”). The terms “diagnostic” and “screening” are used as values of the Reason for exam attribute, and these are potentially confusing for two reasons. First, “diagnostic” is often thought of as complementary to “screening,” in which case the terms refer to the patient’s clinical status (i.e. asymptomatic patients undergo “screening” exams, whereas symptomatic patients undergo “diagnostic” exams). However, “diagnostic” is also frequently used in the context of mammography, in which case it is an indicator of the views to be obtained (specifically, that additional non-standard views may be performed), not an indicator of the patient’s symptom status. In both cases, “diagnostic” refers to an exam being performed for the purpose of further work-up. Here we have chosen to model these terms as part of the Reason for exam semantics, rather than the View semantics. Second, the question of screening and diagnostic exams “for what” may be another source of confusion. Here, we take the position that the answer is typically understood: Screening mammography screens for breast cancer; screening colonography screens for colon cancer. Further, note that the use of the terms “diagnostic” and “screening” is intended to be limited to those exams where these are needed to distinguish from some other type of study. We also use the Reason for exam attribute to distinguish studies that are primarily done in the pediatric domain. For example, the codes for bilateral hip ultrasound and cranial ultrasound both have the Reason for exam specified as “for pediatrics”. We do not create separate codes with pediatrics as the Reason for exam in cases where the same study is commonly done in both the adult and pediatric population. For example, “Head CT” will be used for both pediatric and adult studies. Also note that “3D post processing” is included here as a value of the Reason for exam attribute. This refers to image rendering done after image acquisition. Some facilities bill for such renderings, which may be used for surgical planning or other purposes. As a result, these renderings (at least sometimes) constitute an end-product of the exam, and we have thereby chosen to model such processing as a reason for performing the exam. While 3D post processing may also be used simply as a diagnostic tool in image interpretation (and thus not technically a reason for performing the study), we have elected to simply model any description of 3D post processing here. 20 RadLex-LOINC Harmonized User Guide June 28, 2016 7.2 EXAMPLES <Reason(s)> XR Eye Foreign body MG Breast Diagnostic MG Breast Diagnostic + Call back US Pregnancy + Less than 14 weeks US Multiple gestation + Greater than 14 weeks NM Stomach Liquid gastric emptying CT Heart Calcium score 7.3 NOTES 1. 2. 3. 4. 10/17/14: Values removed - “mass,” “obstruction,” “patency,” “pre op” 10/17/14: Values added – “intra op,” “endograft” 10/17/14: “Twin pregnancy” replaced with “multiple gestation.” “Call back” is only to be used in relation to mammography. 21 RadLex-LOINC Harmonized User Guide June 28, 2016 8 GUIDANCE 8.1 DEFINITIONS The Guidance attribute is used to describe image-guided interventions. Such procedures may range from the very general (e.g. “CT guided needle placement”) to the very specific (e.g. “fluoroscopy guided lumbar vertebroplasty, with bone biopsy, additional level”). Some procedures may also be ambiguous (e.g. “image guided fine needle aspiration and/or core biopsy”). Imaging guidance for procedures is modeled with three sub-attributes: <Approach> <Action> <Object> Approach refers to the primary route of access used, such as percutaneous, transcatheter, or transhepatic. Action indicates the intervention performed, such as biopsy, aspiration, or ablation. Object is used to specify the target of the action, such as mass, abscess or cyst. For complex procedures, operators may be used to combine instances of the Guidance attribute. 8.2 USAGE NOTES 8.2.1 Guidance for.Approach The approach sub-attribute will generally be included in the formal code specification. For some procedures like needle biopsy, the percutaneous route is the “default” and often assumed route. Local procedure names will often not include the word “percutaneous” in the name. For purposes of modeling, we will include percutaneous in the attribute specification. But, to avoid extraneous “clutter”, the display name for the pre-coordinated term will only include the approach if we have two variants, one with percutaneous and one with some other route. In some cases, “percutaneous” may be part of the overall route used for a procedure (e.g. “percutaneous transhepatic”). In such cases, the primary, or most evocative, route will be used (e.g. “transhepatic”). 8.2.2 Guidance for.Action The action sub-attribute will generally be required to adequately specify an image-guided procedure. Examples include: placement of; replacement/exchange of; removal of; repositioning of; retrieval of; infusion of; injection of; localization of; check of. 22 RadLex-LOINC Harmonized User Guide June 28, 2016 8.2.3 Anatomic Location and Guidance for.Object For a given procedure, the body region or organ of interest is specified outside of the Guidance attribute, using the Anatomic Location attribute. On the other hand, when there is a specific site of pathology targeted by an intervention, this is modeled using the Guidance for.Object sub-attribute. The expectation is that when normal anatomic specifiers such as “liver” or “abdomen” are used, these are modeled using Anatomic Location. When a site of disease such as “mass” or “abscess” is described, this is modeled using Guidance for.Object. Alternatively, the object of a procedure may be a device (e.g. “central venous catheter”). Note that the object sub-attribute is optional. Some procedures will not specify a particular pathologic lesion (e.g. “CT guided liver biopsy”) whereas others will (e.g. “CT guided liver mass biopsy”). In some cases, neither Anatomic Location nor Guidance for.Object will be specified (e.g. “US guided fine needle aspiration”). 8.2.4 Modality attribute The Guidance attribute will generally be used in conjunction with the Modality attribute. Recall that the modality code “RP” is used for image-guided procedures where the particular imaging modality is not specified (e.g. “image guided liver biopsy”). 8.2.5 Specifying more than one procedure Although uncommon, the syntax above can also be used to specify more than one procedure by repeating the triplet of sub-attributes. As defined in the Syntax section (2.1), use of “+” to join two procedures means logical conjunction (i.e. both procedures were done). Use of “&or” to join two procedures means logical (inclusive) disjunction (i.e. either or both procedures were done). For example: Guidance for fine needle aspiration &or core needle biopsy This term illustrates how the more generic concept of a “needle biopsy” (including both aspiration and core needle) could be represented. Both procedures in the pair could use whichever sub-attributes of the triplet were appropriate. 23 RadLex-LOINC Harmonized User Guide June 28, 2016 8.3 EXAMPLES <Anatomic Loc> <Approach> <Action> CT Liver Percutaneous Core biopsy CT Liver Percutaneous Core biopsy Mass RP Percutaneous Placement Drain RP Percutaneous Drainage Abscess Transhepatic Placement Drain US Percutaneous Placement Non-tunneled CVC RP Percutaneous Fine needle aspiration &or Core needle biopsy RP Gallbladder <Object> US Pleural space Percutaneous Drainage US Thyroid Percutaneous Fine needle aspiration Percutaneous Exchange RP Gastrojejunal tube 24 RadLex-LOINC Harmonized User Guide June 28, 2016 9 SUBJECT 9.1 DEFINITIONS The Subject attribute is intended for use when there is a need to distinguish between the patient associated with an imaging study, and the target of the study. This situation may occur for pregnant patients undergoing prenatal imaging exams. The potential for multiple gestation further motivates the need for the Subject attribute, as an exam may be targeted at a particular one of multiple fetuses. The Subject attribute may also be used in cases of surgical specimens, such as specimen radiographs at lumpectomy. 25 RadLex-LOINC Harmonized User Guide June 28, 2016 10 REFERENCES 1. http://dicom.nema.org/Dicom/News/oct2013/docs_oct2013/sup121_pc.pdf, Accessed 14 May 2016. 2. http://dicom.nema.org/medical/dicom/current/output/pdf/part03.pdf, Accessed 14 May 2016. 26 RadLex-LOINC Harmonized User Guide June 28, 2016